nasdaq:clvs
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clovisoncology.com
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clovisoncology.com
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Jul 1st, 2018 12:00AM
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Key Account Manager - Germany
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Open
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Commercial
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Munich, DE
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Munich
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DEU
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Jun 18th, 2018 12:00AM
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<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Summary
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><em> </em></span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">The Key </span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Account Manager (KAM) is responsible for the sales performance of Clovis Oncology products in the area assigned. The KAM is also responsible for preventing, finding and removing obstacles which could limit or delay product access to patients
</span><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;"><br />
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">
</span></strong></p>
<span style="color: rgb(0, 0, 0);"><strong><span style="font-family: Times New Roman; font-size: 16px;"> </span></strong></span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><strong><span style="color: rgb(0, 0, 0);"><em> </em></span></strong></span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Responsibilities:</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Sales Accountability:</span></em></strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"></span></em></p>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"> </span></em></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Ensures regional/local formulary product approvals and regional reimbursement activities
<br />
• Responsible for maximizing sales of our brands in the defined territory. This will be measured in the form of sales vs target, market growth or market share
<br />
• Identify and assess market opportunities and decide on tactics in collaboration with the local team in order to maximize on the business opportunity. Achieve expected levels of activity across key customer groups
<br />
• Segment local accounts according to potential and advocacy and to use such analysis to inform territory/account planning
<br />
• Prepare a robust account plan for each account to achieve business objectives, including time investment and personal resources would be best deployed
<br />
• Utilize a level of product and therapeutic disease working knowledge to promote the appropriate use of Clovis Oncology products to healthcare professionals in a specific geographic area
<br />
• Develop and maintains a high level of product and disease area knowledge, demonstrating ability to digest, interpret and share clinical data with customers (face to face or group environment) in a professional way
<br />
• Understand local policies relating to the adoption and funding for cancer treatments
<br />
• Support and ensure the development of documents for granting formulary listing product inclusion at regional and account level
<br />
• Monitor performance evolution, ensuring follow up of action plans, developing required qualitative and quantitative monthly sales reports
<br />
• Ensure accurate and prompt reporting in CRM system, completing necessary administrative tasks in a timely manner
<br />
• Support local process in hospital tendering in line with commercial policies
</p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;"> </span></em></strong></p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">Stakeholder Engagement</span></em></strong><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">: </span></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Identify and pursue opportunities to build relationships with relevant stakeholders to positively influence appropriate prescribing and access decisions for Clovis Oncology products to eligible patients
<br />
• Monitor market trends, competitor products and customer need to identify new business objectives and supports identification and ongoing development of Key Opinion Leaders (local, regional & national)
<br />
• Identify and interact with Key Opinion Leaders and other relevant stakeholders in the territory
<br />
• Identify key commissioners, fund holders and partner with them to ensure availability of Clovis Oncology brands
<br />
• Contribute and adhere to the brand plans to reach sales targets, based on customer insights and in accordance to set strategy for our brands as well as develop & manage relationships with key customers and stakeholders
<br />
• Gather and interpret relevant data and insights, through customer and stakeholder interaction, as well as other available sources
<br />
• To be a member of and contribute to internal project groups; e.g. oncology product advisory group
<br />
• Provide timely feedback to all relevant internal stakeholders
</p>
<p><strong><em>Account Management:</em></strong></p>
<p>• Where the role has scope across a country, the KAM will be required to deliver agreed national level accountabilities that may require delivery against HTA and other access related tasks as defined and delegated by the Access Lead <br />
• Leverage cross-functional relationship with medical, marketing and other functions to design and execute on a Key Account Management strategy for territory and deliver required performance of the accounts <br />
• Initiate and lead customer activities and defined sales/marketing projects in the territory <br />
• Facilitate customer education in relevant disease areas to increase awareness of best practice and clinical advantages of products <br />
• Develop therapeutic and market expertise within designated therapy areas <br />
• Utilize the wider resources from Head Office, such as Medical, Outcomes models, marketing, OPAG’s <br />
• Share and communicate market knowledge and customer insights internally with the Specialty Care Team members </p>
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Jun 30th, 2018 10:38PM
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Jun 30th, 2018 10:38PM
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Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
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clovisoncology.com
|
clovisoncology.com
|
Jul 7th, 2018 12:00AM
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Key Account Manager - Germany
|
Open
|
|
Commercial
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Munich, DE
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Munich
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|
DEU
|
Jun 18th, 2018 12:00AM
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|
<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Summary
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><em> </em></span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">The Key </span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Account Manager (KAM) is responsible for the sales performance of Clovis Oncology products in the area assigned. The KAM is also responsible for preventing, finding and removing obstacles which could limit or delay product access to patients
</span><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;"><br />
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">
</span></strong></p>
<span style="color: rgb(0, 0, 0);"><strong><span style="font-family: Times New Roman; font-size: 16px;"> </span></strong></span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><strong><span style="color: rgb(0, 0, 0);"><em> </em></span></strong></span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Responsibilities:</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Sales Accountability:</span></em></strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"></span></em></p>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"> </span></em></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Ensures regional/local formulary product approvals and regional reimbursement activities
<br />
• Responsible for maximizing sales of our brands in the defined territory. This will be measured in the form of sales vs target, market growth or market share
<br />
• Identify and assess market opportunities and decide on tactics in collaboration with the local team in order to maximize on the business opportunity. Achieve expected levels of activity across key customer groups
<br />
• Segment local accounts according to potential and advocacy and to use such analysis to inform territory/account planning
<br />
• Prepare a robust account plan for each account to achieve business objectives, including time investment and personal resources would be best deployed
<br />
• Utilize a level of product and therapeutic disease working knowledge to promote the appropriate use of Clovis Oncology products to healthcare professionals in a specific geographic area
<br />
• Develop and maintains a high level of product and disease area knowledge, demonstrating ability to digest, interpret and share clinical data with customers (face to face or group environment) in a professional way
<br />
• Understand local policies relating to the adoption and funding for cancer treatments
<br />
• Support and ensure the development of documents for granting formulary listing product inclusion at regional and account level
<br />
• Monitor performance evolution, ensuring follow up of action plans, developing required qualitative and quantitative monthly sales reports
<br />
• Ensure accurate and prompt reporting in CRM system, completing necessary administrative tasks in a timely manner
<br />
• Support local process in hospital tendering in line with commercial policies
</p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;"> </span></em></strong></p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">Stakeholder Engagement</span></em></strong><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">: </span></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Identify and pursue opportunities to build relationships with relevant stakeholders to positively influence appropriate prescribing and access decisions for Clovis Oncology products to eligible patients
<br />
• Monitor market trends, competitor products and customer need to identify new business objectives and supports identification and ongoing development of Key Opinion Leaders (local, regional & national)
<br />
• Identify and interact with Key Opinion Leaders and other relevant stakeholders in the territory
<br />
• Identify key commissioners, fund holders and partner with them to ensure availability of Clovis Oncology brands
<br />
• Contribute and adhere to the brand plans to reach sales targets, based on customer insights and in accordance to set strategy for our brands as well as develop & manage relationships with key customers and stakeholders
<br />
• Gather and interpret relevant data and insights, through customer and stakeholder interaction, as well as other available sources
<br />
• To be a member of and contribute to internal project groups; e.g. oncology product advisory group
<br />
• Provide timely feedback to all relevant internal stakeholders
</p>
<p><strong><em>Account Management:</em></strong></p>
<p>• Where the role has scope across a country, the KAM will be required to deliver agreed national level accountabilities that may require delivery against HTA and other access related tasks as defined and delegated by the Access Lead <br />
• Leverage cross-functional relationship with medical, marketing and other functions to design and execute on a Key Account Management strategy for territory and deliver required performance of the accounts <br />
• Initiate and lead customer activities and defined sales/marketing projects in the territory <br />
• Facilitate customer education in relevant disease areas to increase awareness of best practice and clinical advantages of products <br />
• Develop therapeutic and market expertise within designated therapy areas <br />
• Utilize the wider resources from Head Office, such as Medical, Outcomes models, marketing, OPAG’s <br />
• Share and communicate market knowledge and customer insights internally with the Specialty Care Team members </p>
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Jul 6th, 2018 11:01PM
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Jul 6th, 2018 11:01PM
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Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jul 8th, 2018 12:00AM
|
Key Account Manager - Germany
|
Open
|
|
Commercial
|
Munich, DE
|
Munich
|
|
DEU
|
Jun 18th, 2018 12:00AM
|
|
<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Summary
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><em> </em></span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">The Key </span><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Account Manager (KAM) is responsible for the sales performance of Clovis Oncology products in the area assigned. The KAM is also responsible for preventing, finding and removing obstacles which could limit or delay product access to patients
</span><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;"><br />
</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">
</span></strong></p>
<span style="color: rgb(0, 0, 0);"><strong><span style="font-family: Times New Roman; font-size: 16px;"> </span></strong></span>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"><strong><span style="color: rgb(0, 0, 0);"><em> </em></span></strong></span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;">Job Responsibilities:</span></strong></p>
<p style="margin: 0cm 0cm 0pt;"><strong><span style="font-family: 'Calibri',sans-serif; font-size: 11pt; text-decoration: underline;"> </span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;"> </span>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Sales Accountability:</span></em></strong><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"></span></em></p>
<p style="margin: 0cm 0cm 0pt; text-align: justify;"><em><span style="font-family: 'Calibri',sans-serif; font-size: 13px;"> </span></em></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Ensures regional/local formulary product approvals and regional reimbursement activities
<br />
• Responsible for maximizing sales of our brands in the defined territory. This will be measured in the form of sales vs target, market growth or market share
<br />
• Identify and assess market opportunities and decide on tactics in collaboration with the local team in order to maximize on the business opportunity. Achieve expected levels of activity across key customer groups
<br />
• Segment local accounts according to potential and advocacy and to use such analysis to inform territory/account planning
<br />
• Prepare a robust account plan for each account to achieve business objectives, including time investment and personal resources would be best deployed
<br />
• Utilize a level of product and therapeutic disease working knowledge to promote the appropriate use of Clovis Oncology products to healthcare professionals in a specific geographic area
<br />
• Develop and maintains a high level of product and disease area knowledge, demonstrating ability to digest, interpret and share clinical data with customers (face to face or group environment) in a professional way
<br />
• Understand local policies relating to the adoption and funding for cancer treatments
<br />
• Support and ensure the development of documents for granting formulary listing product inclusion at regional and account level
<br />
• Monitor performance evolution, ensuring follow up of action plans, developing required qualitative and quantitative monthly sales reports
<br />
• Ensure accurate and prompt reporting in CRM system, completing necessary administrative tasks in a timely manner
<br />
• Support local process in hospital tendering in line with commercial policies
</p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;"> </span></em></strong></p>
<p><strong><em><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">Stakeholder Engagement</span></em></strong><span style="color: rgb(51, 51, 51); font-family: 'Calibri',sans-serif; font-size: 11pt;">: </span></p>
<p><span style="font-family: Times New Roman; font-size: 16px;"> </span>• Identify and pursue opportunities to build relationships with relevant stakeholders to positively influence appropriate prescribing and access decisions for Clovis Oncology products to eligible patients
<br />
• Monitor market trends, competitor products and customer need to identify new business objectives and supports identification and ongoing development of Key Opinion Leaders (local, regional & national)
<br />
• Identify and interact with Key Opinion Leaders and other relevant stakeholders in the territory
<br />
• Identify key commissioners, fund holders and partner with them to ensure availability of Clovis Oncology brands
<br />
• Contribute and adhere to the brand plans to reach sales targets, based on customer insights and in accordance to set strategy for our brands as well as develop & manage relationships with key customers and stakeholders
<br />
• Gather and interpret relevant data and insights, through customer and stakeholder interaction, as well as other available sources
<br />
• To be a member of and contribute to internal project groups; e.g. oncology product advisory group
<br />
• Provide timely feedback to all relevant internal stakeholders
</p>
<p><strong><em>Account Management:</em></strong></p>
<p>• Where the role has scope across a country, the KAM will be required to deliver agreed national level accountabilities that may require delivery against HTA and other access related tasks as defined and delegated by the Access Lead <br />
• Leverage cross-functional relationship with medical, marketing and other functions to design and execute on a Key Account Management strategy for territory and deliver required performance of the accounts <br />
• Initiate and lead customer activities and defined sales/marketing projects in the territory <br />
• Facilitate customer education in relevant disease areas to increase awareness of best practice and clinical advantages of products <br />
• Develop therapeutic and market expertise within designated therapy areas <br />
• Utilize the wider resources from Head Office, such as Medical, Outcomes models, marketing, OPAG’s <br />
• Share and communicate market knowledge and customer insights internally with the Specialty Care Team members </p>
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Jul 7th, 2018 10:49PM
|
Jul 7th, 2018 10:49PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Dec 19th, 2018 12:00AM
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Assistant-DACH
|
Open
|
|
Commercial
|
Munich, DE
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Munich
|
|
DEU
|
Dec 14th, 2018 12:00AM
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<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: underline; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Job Summary</span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; text-align: justify; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">This role is
responsible for managing and coordinating a comprehensive, confidential and
high quality administrative service to the German Commercial (primarily field
based) and Medical Teams. You will be responsible for setting up and
implementing new office systems and processes, including developing appropriate
administrative processes. <strong style="mso-bidi-font-weight: normal;">Reporting to
the General Manager – DACH, you will also provide support to the local
Leadership Team over a full range of operational duties.</strong></span></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; text-align: justify; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; text-align: justify; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">This position
requires a self-starter needing minimal supervision and willing to take on a
wide range of responsibilities outside the defined responsibilities.<span style="mso-spacerun: yes;"> </span>Coordination of all support services to
ensure efficient functioning of the Clovis Oncology Munich Office. <span style="mso-spacerun: yes;"> </span>A flexible, ‘can do’ approach and with a
strong work ethic and ability to take proactive ownership of assigned duties. </span></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: underline; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Job
Responsibilities</span></strong></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<p style="margin: 0cm 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></p>
<span style="font-family: Times New Roman; font-size: 16px;">
</span>
<ul>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Coordinating
internal and external team meetings so that they run smoothly, including
scheduling meeting times, making travel arrangements for attendees and ensuring
that various meeting amenities are available.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Coordinate
conference attendance, National Congresses (European and National),
registrations, hotel bookings.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Support
visitors to Munich, which may include assisting them with travel arrangements.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Liaising with
external Governing Boards/Payer Physician Influencers. </span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Preparing
expense reports, submitting invoices to Germany and US office for payment.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Managing
contract requests, primarily CDAs with consultants, vendors, investigators, as
needed and submit partially/fully executed contracts to Boulder Office Manager
for final processing.</span></li>
<li style="margin: 0cm 0cm 0pt 18pt;"><span style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-bidi-font-size: 11.0pt;">Supporting
management of EU budget submission throughout development, execution and
reporting phases.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Preparing
Word/Excel/PowerPoint presentations/minutes/reports.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Maintaining
Quality documents for Munich Office:<span style="mso-spacerun: yes;">
</span>SOPs, Policies, Work Instructions and Forms—electronic and paper
files.<span style="mso-spacerun: yes;"> </span>Preparing documents, distribute
for reviews, consolidate edits, route for final approval, route for training,
and post to SharePoint.<span style="mso-spacerun: yes;"> </span>Maintaining
training files on all GxP employees and consultants.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Working with
European HR, maintaining training records and onboarding materials for all
employees.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Discreet
handling of sensitive company information to support senior management.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Working with other
administrative assistants in Europe to establish best practice, standards/ways
of working.<span style="mso-spacerun: yes;"> </span></span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">General front
desk duties:<span style="mso-spacerun: yes;"> </span>answer and route calls,
order office supplies, maintain supplies/storage, prepare mail and packages for
USPS and FedEx shipment.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="color: black; font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: Tahoma; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">All day to day
activities to ensure efficient running of the office including facilities
management and compliance with H&S requirements.</span></li>
</ul>
<p style="margin: 0cm 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: underline; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Qualifications</span></strong></p>
<p style="margin: 0cm 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: none; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></strong></p>
<ul>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Significant administrative experience with proven track record of increasing
responsibility and skill development.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Highly flexible team member with the ability to prioritize and work
independently. </span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Solid skills in managing office technology and confidential record
keeping.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Excellent organizational skills with an ability to prioritize workload,
plan ahead and multi-task.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Excellent written and communication skills, problem-solving and team
working skills.<span style="mso-spacerun: yes;"> </span></span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Experience of working in a matrix-working environment with individuals in
different countries and levels of authority. </span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Desire to learn new skills and look for additional opportunities to
contribute.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Proactive approach to improving system efficiencies and office culture.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Experience in providing administrative support to senior management.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Ability to think beyond boundaries of own job, challenge status quo and
seek opportunities for continuous improvement.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">High level of confidentiality and discretion. </span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Working with external agencies and suppliers; leveraging efficiency and
budget management.</span></li>
</ul>
<p style="margin: 0cm 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: none; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></strong></p>
<p style="margin: 12pt 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: underline; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Education and Experience</span></strong></p>
<p style="margin: 12pt 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: none; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"> </span></strong></p>
<ul>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Good standard of education, formal secretarial training and/or degree
preferred. </span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">A minimum of 5 years administrative work experience required.<span style="mso-spacerun: yes;"> </span></span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Must have excellent time management, organizational, customer service and
interpersonal skills, with demonstrated ability to produce high quality work
under tight deadlines.<span style="mso-spacerun: yes;"> </span></span></li>
<li style="margin: 12pt 0cm 0pt 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Excellent technical skills to include but not limited to Microsoft Office
Suite (Word, PowerPoint, Excel, Outlook) and desktop publishing/project
management skills.</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Fluent in English</span></li>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-weight: bold; mso-bidi-font-size: 11.0pt;">Ideally, experience of local German Policies and Laws </span></li>
</ul>
<p style="margin: 12pt 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span style="font-family: Times New Roman; font-size: 16px;">
</span></p>
<p style="margin: 12pt 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><strong><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; text-decoration: underline; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Working Conditions</span></strong></p>
<ul>
<li style="margin: 1em 0px 1em 18pt; mso-outline-level: 4; mso-add-space: auto; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;">Office-based
position with minimum travel required.</span></li>
</ul>
<p style="margin: 0cm 0cm 0pt; mso-outline-level: 4; mso-layout-grid-align: auto; punctuation-wrap: hanging; mso-vertical-align-alt: auto;"><span lang="EN-US" style="font-family: 'Calibri',sans-serif; font-size: 16px; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-bidi-font-size: 11.0pt;"></span></p>
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Dec 18th, 2018 11:52PM
|
Dec 18th, 2018 11:52PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 25th, 2018 12:00AM
|
Senior Study Operations Associate
|
Open
|
|
Clinical Operations
|
United Kingdom, England, GB
|
|
|
GBR
|
Dec 12th, 2017 12:00AM
|
|
<strong><span style="text-decoration: underline;">Job Summary
</span></strong><br />
Primarily responsible for in-house study and site management. Activities include: assisting with study start up, enrollment, tracking study metrics, site management, vendor management, and Sponsor Oversight Visits, as requested. Works with Study Team (other Ops Associates, Clinical Operations Manager, Data Management, Supply Chain, and Medical Monitors, etc) to ensure successful planning, execution, and completion of clinical trials within expected timelines.
<br />
<br />
<strong><span style="text-decoration: underline;">Job Responsibilities
</span></strong><br />
<br />
• Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
<br />
• Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
<br />
• Assist with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
<br />
• Assist with evaluating, selecting, and managing clinical study sites.
<br />
• Assist in the evaluation, oversight and management of CROs and other vendors and systems.
<br />
• Assist with negotiation and co-management of contracts/budgets with CROs and other vendors.
<br />
• Provide input to and co-manage project objectives to meet timelines and deliverables.
<br />
• Responsible for tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
<br />
• Assist with the analysis and development of action plans to address issues with investigational sites and/or CROs.
<br />
• Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
<br />
• Assist in training/mentoring new team members on specific study processes, as required/appropriate.
<br />
• Serve as a primary contact for Investigator sites.
<br />
• Review and provide input to regulatory documents (Clinical Trial Application documents/CEC application documents/IRAS/R&D forms).
<br />
• Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues.
<br />
• Review and negotiate clinical site study contracts and budgets.
<br />
• Assist with the planning, coordination and presentations at Investigator Meetings and CRA Training meetings as requested.
<br />
• Attend/accompany the CRO personnel on the various site visits as applicable sponsor oversight visits as required/requested.
<br />
• Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.
<br />
• Assist with the management of internal trial master files.
<br />
• Assist and provide input to the creation/revision/review of departmental SOPs.
<br />
|
|
|
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|
Jun 25th, 2018 04:31PM
|
Jun 25th, 2018 04:31PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 25th, 2018 12:00AM
|
Senior Study Operations Associate
|
Open
|
|
Clinical Operations
|
United Kingdom, England, GB
|
|
|
GBR
|
Feb 2nd, 2018 12:00AM
|
|
<strong><span style="text-decoration: underline;">Job Summary
</span></strong><br />
Primarily responsible for in-house study and site management. Activities include: assisting with study start up, enrollment, tracking study metrics, site management, vendor management, and Sponsor Oversight Visits, as requested. Works with Study Team (other Ops Associates, Clinical Operations Manager, Data Management, Supply Chain, and Medical Monitors, etc) to ensure successful planning, execution, and completion of clinical trials within expected timelines.
<br />
<br />
<strong><span style="text-decoration: underline;">Job Responsibilities
</span></strong><br />
<br />
• Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
<br />
• Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
<br />
• Assist with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
<br />
• Assist with evaluating, selecting, and managing clinical study sites.
<br />
• Assist in the evaluation, oversight and management of CROs and other vendors and systems.
<br />
• Assist with negotiation and co-management of contracts/budgets with CROs and other vendors.
<br />
• Provide input to and co-manage project objectives to meet timelines and deliverables.
<br />
• Responsible for tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
<br />
• Assist with the analysis and development of action plans to address issues with investigational sites and/or CROs.
<br />
• Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
<br />
• Assist in training/mentoring new team members on specific study processes, as required/appropriate.
<br />
• Serve as a primary contact for Investigator sites.
<br />
• Review and provide input to regulatory documents (Clinical Trial Application documents/CEC application documents/IRAS/R&D forms).
<br />
• Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues.
<br />
• Review and negotiate clinical site study contracts and budgets.
<br />
• Assist with the planning, coordination and presentations at Investigator Meetings and CRA Training meetings as requested.
<br />
• Attend/accompany the CRO personnel on the various site visits as applicable sponsor oversight visits as required/requested.
<br />
• Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.
<br />
• Assist with the management of internal trial master files.
<br />
• Assist and provide input to the creation/revision/review of departmental SOPs.
<br />
|
|
|
|
|
Jun 25th, 2018 04:31PM
|
Jun 25th, 2018 04:31PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 25th, 2018 12:00AM
|
Director, GVP Quality Assurance
|
Open
|
|
Quality Assurance
|
United Kingdom, England, GB
|
|
|
GBR
|
Jun 12th, 2018 12:00AM
|
|
<p><strong><span style="text-decoration: underline;">Job Summary</span></strong></p>
<p>The Director, GVP Quality Assurance, is responsible for establishing the vision and implementing the associated strategy for the Pharmacovigilance (PV) Quality Assurance (QA) function. The Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within Clovis Oncology throughout all phases of the product development life cycle, including pre-clinical, clinical and post-marketing stages globally. Responsibilities include development and execution of internal and external Pharmacovigilance (PV) audit programs, as well as providing leadership for Pharmacovigilance-focused health authority inspections. In addition, the Director, GVP Quality Assurance will monitor the performance and effectiveness of the pharmacovigilance system and its quality system by providing independent Pharmacovigilance-related oversight of the implementation of the Clovis Oncology quality systems: training, deviations, corrective and preventive actions (CAPA), risk management and policies/procedures/work instructions. An equally important responsibility is to act as liaison for other quality assurance colleagues and the Pharmacovigilance colleagues, especially as it relates to the Pharmacovigilance System Master File (PSMF).</p>
<p>Thorough knowledge of global regulations and guidelines is required. Experience working in a virtual pharmaceutical environment is highly desired.</p>
<p><strong><span style="text-decoration: underline;">Job Responsibilities</span></strong></p>
<p>• Develop, implement and maintain the risk-based internal and external (vendor) PV audit programs, including risk strategy, tactical and operational audit planning:<br />
o Ensure PV audits are scheduled, conducted and reported as planned<br />
o Ensure PV audit CAPAs are established, agreed and tracked to closure<br />
o Ensure PV audit metrics are prepared, analyzed and improvements instituted<br />
• Direct global PV inspection activities:<br />
o Identify and prepare all necessary departments for likely PV inspections<br />
o Conduct mock inspections as appropriate<br />
o Manage activities of subject matter experts and support staff during inspections<br />
o Ensure timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure<br />
• Provide input into applicable new PV vendor contracts<br />
• Support PV training:<br />
o Review training presentations, training records and training compliance reports<br />
o Participate in planning, oversight and conduct of PV training, as required<br />
• Oversee deviations impacting on PV:<br />
o Identify and monitor deviations impacting on PV<br />
o Ensure CAPA resolutions are established<br />
o Verify effectiveness of the CAPA resolutions<br />
• Assist risk assessment implementation within PV and QA processes<br />
• Identify strategies to enhance GVP compliance and PV QA efficiencies<br />
• Provide critical review and approval of PV department policies/procedures/work instructions<br />
• Support periodic assessment of PV department policies/procedures/work instructions<br />
• Provide critical review of quality systems procedures from a PV QA compliance perspective<br />
• Write or update PV-focused QA departmental procedures<br />
• Provide critical review of PV department documentation, including vendor oversight management plans, business continuity plans, disaster recovery and other operational documentation, as needed<br />
• Participate in PV and QA department computer system selection and implementation, including review and approval or execution of protocols, scripts and reports, as assigned<br />
• Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations<br />
• Provide EU QPPV with necessary QA data allowing oversight of the PV quality system<br />
• Participate in resolution and oversight of quality events impacting on PV compliance such as ransomware attacks, recalls, etc.<br />
• Manage GVP QA documentation archiving process<br />
• Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics<br />
• Monitor, analyze and communicate PV regulation, guidance and trend changes<br />
• Coordinate with GMP QA, GCP QA and QS colleagues ensuring harmonized quality approaches<br />
• Attend company, departmental and cross-functional meetings as required<br />
• Report to supervisor on project progress, issues, and problem solving</p>
<br />
|
|
|
|
|
Jun 25th, 2018 04:31PM
|
Jun 25th, 2018 04:31PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 26th, 2018 12:00AM
|
Director, GVP Quality Assurance
|
Open
|
|
Quality Assurance
|
United Kingdom, England, GB
|
|
|
GBR
|
Jun 12th, 2018 12:00AM
|
|
<p><strong><span style="text-decoration: underline;">Job Summary</span></strong></p>
<p>The Director, GVP Quality Assurance, is responsible for establishing the vision and implementing the associated strategy for the Pharmacovigilance (PV) Quality Assurance (QA) function. The Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within Clovis Oncology throughout all phases of the product development life cycle, including pre-clinical, clinical and post-marketing stages globally. Responsibilities include development and execution of internal and external Pharmacovigilance (PV) audit programs, as well as providing leadership for Pharmacovigilance-focused health authority inspections. In addition, the Director, GVP Quality Assurance will monitor the performance and effectiveness of the pharmacovigilance system and its quality system by providing independent Pharmacovigilance-related oversight of the implementation of the Clovis Oncology quality systems: training, deviations, corrective and preventive actions (CAPA), risk management and policies/procedures/work instructions. An equally important responsibility is to act as liaison for other quality assurance colleagues and the Pharmacovigilance colleagues, especially as it relates to the Pharmacovigilance System Master File (PSMF).</p>
<p>Thorough knowledge of global regulations and guidelines is required. Experience working in a virtual pharmaceutical environment is highly desired.</p>
<p><strong><span style="text-decoration: underline;">Job Responsibilities</span></strong></p>
<p>• Develop, implement and maintain the risk-based internal and external (vendor) PV audit programs, including risk strategy, tactical and operational audit planning:<br />
o Ensure PV audits are scheduled, conducted and reported as planned<br />
o Ensure PV audit CAPAs are established, agreed and tracked to closure<br />
o Ensure PV audit metrics are prepared, analyzed and improvements instituted<br />
• Direct global PV inspection activities:<br />
o Identify and prepare all necessary departments for likely PV inspections<br />
o Conduct mock inspections as appropriate<br />
o Manage activities of subject matter experts and support staff during inspections<br />
o Ensure timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure<br />
• Provide input into applicable new PV vendor contracts<br />
• Support PV training:<br />
o Review training presentations, training records and training compliance reports<br />
o Participate in planning, oversight and conduct of PV training, as required<br />
• Oversee deviations impacting on PV:<br />
o Identify and monitor deviations impacting on PV<br />
o Ensure CAPA resolutions are established<br />
o Verify effectiveness of the CAPA resolutions<br />
• Assist risk assessment implementation within PV and QA processes<br />
• Identify strategies to enhance GVP compliance and PV QA efficiencies<br />
• Provide critical review and approval of PV department policies/procedures/work instructions<br />
• Support periodic assessment of PV department policies/procedures/work instructions<br />
• Provide critical review of quality systems procedures from a PV QA compliance perspective<br />
• Write or update PV-focused QA departmental procedures<br />
• Provide critical review of PV department documentation, including vendor oversight management plans, business continuity plans, disaster recovery and other operational documentation, as needed<br />
• Participate in PV and QA department computer system selection and implementation, including review and approval or execution of protocols, scripts and reports, as assigned<br />
• Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations<br />
• Provide EU QPPV with necessary QA data allowing oversight of the PV quality system<br />
• Participate in resolution and oversight of quality events impacting on PV compliance such as ransomware attacks, recalls, etc.<br />
• Manage GVP QA documentation archiving process<br />
• Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics<br />
• Monitor, analyze and communicate PV regulation, guidance and trend changes<br />
• Coordinate with GMP QA, GCP QA and QS colleagues ensuring harmonized quality approaches<br />
• Attend company, departmental and cross-functional meetings as required<br />
• Report to supervisor on project progress, issues, and problem solving</p>
<br />
|
|
|
|
|
Jun 25th, 2018 11:02PM
|
Jun 25th, 2018 11:02PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 27th, 2018 12:00AM
|
Senior Study Operations Associate
|
Open
|
|
Clinical Operations
|
United Kingdom, England, GB
|
|
|
GBR
|
Feb 2nd, 2018 12:00AM
|
|
<strong><span style="text-decoration: underline;">Job Summary
</span></strong><br />
Primarily responsible for in-house study and site management. Activities include: assisting with study start up, enrollment, tracking study metrics, site management, vendor management, and Sponsor Oversight Visits, as requested. Works with Study Team (other Ops Associates, Clinical Operations Manager, Data Management, Supply Chain, and Medical Monitors, etc) to ensure successful planning, execution, and completion of clinical trials within expected timelines.
<br />
<br />
<strong><span style="text-decoration: underline;">Job Responsibilities
</span></strong><br />
<br />
• Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
<br />
• Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
<br />
• Assist with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
<br />
• Assist with evaluating, selecting, and managing clinical study sites.
<br />
• Assist in the evaluation, oversight and management of CROs and other vendors and systems.
<br />
• Assist with negotiation and co-management of contracts/budgets with CROs and other vendors.
<br />
• Provide input to and co-manage project objectives to meet timelines and deliverables.
<br />
• Responsible for tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
<br />
• Assist with the analysis and development of action plans to address issues with investigational sites and/or CROs.
<br />
• Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
<br />
• Assist in training/mentoring new team members on specific study processes, as required/appropriate.
<br />
• Serve as a primary contact for Investigator sites.
<br />
• Review and provide input to regulatory documents (Clinical Trial Application documents/CEC application documents/IRAS/R&D forms).
<br />
• Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues.
<br />
• Review and negotiate clinical site study contracts and budgets.
<br />
• Assist with the planning, coordination and presentations at Investigator Meetings and CRA Training meetings as requested.
<br />
• Attend/accompany the CRO personnel on the various site visits as applicable sponsor oversight visits as required/requested.
<br />
• Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.
<br />
• Assist with the management of internal trial master files.
<br />
• Assist and provide input to the creation/revision/review of departmental SOPs.
<br />
|
|
|
|
|
Jun 26th, 2018 11:02PM
|
Jun 26th, 2018 11:02PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|
nasdaq:clvs
|
clovisoncology.com
|
clovisoncology.com
|
Jun 30th, 2018 12:00AM
|
Director, GVP Quality Assurance
|
Open
|
|
Quality Assurance
|
United Kingdom, England, GB
|
|
|
GBR
|
Jun 12th, 2018 12:00AM
|
|
<p><strong><span style="text-decoration: underline;">Job Summary</span></strong></p>
<p>The Director, GVP Quality Assurance, is responsible for establishing the vision and implementing the associated strategy for the Pharmacovigilance (PV) Quality Assurance (QA) function. The Director, GVP Quality Assurance will ensure Good Pharmacovigilance Practice (GVP) within Clovis Oncology throughout all phases of the product development life cycle, including pre-clinical, clinical and post-marketing stages globally. Responsibilities include development and execution of internal and external Pharmacovigilance (PV) audit programs, as well as providing leadership for Pharmacovigilance-focused health authority inspections. In addition, the Director, GVP Quality Assurance will monitor the performance and effectiveness of the pharmacovigilance system and its quality system by providing independent Pharmacovigilance-related oversight of the implementation of the Clovis Oncology quality systems: training, deviations, corrective and preventive actions (CAPA), risk management and policies/procedures/work instructions. An equally important responsibility is to act as liaison for other quality assurance colleagues and the Pharmacovigilance colleagues, especially as it relates to the Pharmacovigilance System Master File (PSMF).</p>
<p>Thorough knowledge of global regulations and guidelines is required. Experience working in a virtual pharmaceutical environment is highly desired.</p>
<p><strong><span style="text-decoration: underline;">Job Responsibilities</span></strong></p>
<p>• Develop, implement and maintain the risk-based internal and external (vendor) PV audit programs, including risk strategy, tactical and operational audit planning:<br />
o Ensure PV audits are scheduled, conducted and reported as planned<br />
o Ensure PV audit CAPAs are established, agreed and tracked to closure<br />
o Ensure PV audit metrics are prepared, analyzed and improvements instituted<br />
• Direct global PV inspection activities:<br />
o Identify and prepare all necessary departments for likely PV inspections<br />
o Conduct mock inspections as appropriate<br />
o Manage activities of subject matter experts and support staff during inspections<br />
o Ensure timely responses to inspection findings are prepared, submitted and associated CAPAs tracked to closure<br />
• Provide input into applicable new PV vendor contracts<br />
• Support PV training:<br />
o Review training presentations, training records and training compliance reports<br />
o Participate in planning, oversight and conduct of PV training, as required<br />
• Oversee deviations impacting on PV:<br />
o Identify and monitor deviations impacting on PV<br />
o Ensure CAPA resolutions are established<br />
o Verify effectiveness of the CAPA resolutions<br />
• Assist risk assessment implementation within PV and QA processes<br />
• Identify strategies to enhance GVP compliance and PV QA efficiencies<br />
• Provide critical review and approval of PV department policies/procedures/work instructions<br />
• Support periodic assessment of PV department policies/procedures/work instructions<br />
• Provide critical review of quality systems procedures from a PV QA compliance perspective<br />
• Write or update PV-focused QA departmental procedures<br />
• Provide critical review of PV department documentation, including vendor oversight management plans, business continuity plans, disaster recovery and other operational documentation, as needed<br />
• Participate in PV and QA department computer system selection and implementation, including review and approval or execution of protocols, scripts and reports, as assigned<br />
• Liaise with other QA functions to collate, review and provide requested data and information for the PSMF, Quality Management Reviews, Annual Reports and other reports and presentations<br />
• Provide EU QPPV with necessary QA data allowing oversight of the PV quality system<br />
• Participate in resolution and oversight of quality events impacting on PV compliance such as ransomware attacks, recalls, etc.<br />
• Manage GVP QA documentation archiving process<br />
• Respond to general PV-QA queries and provide advice and guidance to PV Operations, QA and other functional groups in relation to PV topics<br />
• Monitor, analyze and communicate PV regulation, guidance and trend changes<br />
• Coordinate with GMP QA, GCP QA and QS colleagues ensuring harmonized quality approaches<br />
• Attend company, departmental and cross-functional meetings as required<br />
• Report to supervisor on project progress, issues, and problem solving</p>
<br />
|
|
|
|
|
Jun 29th, 2018 10:46PM
|
Jun 29th, 2018 10:46PM
|
Clovis Oncology
|
Health Care
|
Pharmaceuticals & Biotechnology
|