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nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 12th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open Greenwich Biosciences, Inc. UK - Field Based – Cambridge GBR <p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul> Feb 12th, 2022 04:01PM Feb 12th, 2022 04:01PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 12th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open Greenwich Biosciences, Inc. 2 Locations UK - Field Based – Cambridge GBR Jan 19th, 2022 12:00AM <p style="text-align:left"><span>We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul><p></p><p><span>Join Us!</span></p> Feb 12th, 2022 04:01PM Feb 12th, 2022 04:01PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 13th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open Greenwich Biosciences, Inc. UK - Field Based – Cambridge GBR <p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul> Feb 13th, 2022 03:30PM Feb 13th, 2022 03:30PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 13th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open Greenwich Biosciences, Inc. 2 Locations UK - Field Based – Cambridge GBR Jan 19th, 2022 12:00AM <p style="text-align:left"><span>We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul><p></p><p><span>Join Us!</span></p> Feb 13th, 2022 03:30PM Feb 13th, 2022 03:30PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 14th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd UK - Field Based – Cambridge GBR <p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul> Feb 14th, 2022 04:33PM Feb 14th, 2022 04:33PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 14th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd 2 Locations UK - Field Based – Cambridge GBR Feb 14th, 2022 12:00AM <p style="text-align:left"><span>We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul><p></p><p><span>Join Us!</span></p> Feb 14th, 2022 04:33PM Feb 14th, 2022 04:33PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 15th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd UK - Field Based – Cambridge GBR <p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul> Feb 15th, 2022 03:38PM Feb 15th, 2022 03:38PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 15th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd 2 Locations UK - Field Based – Cambridge GBR Feb 14th, 2022 12:00AM <p style="text-align:left"><span>We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul><p></p><p><span>Join Us!</span></p> Feb 15th, 2022 03:38PM Feb 15th, 2022 03:38PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 16th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd 2 Locations UK - Field Based – Cambridge GBR Feb 14th, 2022 12:00AM <p style="text-align:left"><span>We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.</span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul><p></p><p><span>Join Us!</span></p> Feb 16th, 2022 06:04PM Feb 16th, 2022 06:04PM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology
nasdaq:jazz gwpharm.wd3.myworkdayjobs.com gwpharm.wd3.myworkdayjobs.com Feb 18th, 2022 12:00AM Senior Clinical Trials Manager Contractor Open GW Research Ltd UK - Field Based – Cambridge GBR <p><b>Essential Functions</b></p><ul><li><p>Manage external vendors and contract research organizations</p></li><li><p>Prepare study documents such as the Monitoring Manual, Study Operations</p></li><li><p>Manual, Source Data Verification Plan and Laboratory Manual</p></li><li><p>Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents</p></li><li><p>Assist with protocol development and study report completion</p></li><li><p>Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols</p></li><li><p>Provide guidance, direction, and management to CRAs</p></li><li><p>Track patient enrollment, qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities</p></li><li><p>Coordinate study supplies</p></li><li><p>Negotiate contracts with vendors of clinical trial services</p></li><li><p>Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings</p></li><li><p>Assist and support data query process</p></li><li><p>Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines</p></li><li><p>Ensures trial master file is current and maintained</p></li></ul><p></p><p><b>Required Knowledge, Skills, and Abilities</b></p><ul><li><p>At least 5 years of experience in clinical trial management Experience in Oncology is preferred</p></li><li><p>Proven Management of people in a matrixed environment Management of global clinical trials</p></li><li><p>Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations --Demonstrated ability to work independently and in a team environment</p></li><li><p>Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g.Word, Excel, PowerPoint, Outlook)</p></li><li><p>Excellent oral and written communication skills and strong organizational abilities</p></li></ul><p></p><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred</p></li></ul><p></p><p><b>Description of Physical Demands</b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of time</p></li><li><p>Constantly operating a computer, printer, telephone and other similar office machinery</p></li></ul><p></p><p><b>Description of Work Environment</b></p><ul><li><p>Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes</p></li><li><p>Frequent computer use at workstation</p></li><li><p>May move from one work location to another occasionally</p></li><li><p>Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands</p></li><li><p>Occasional public contact requiring appropriate business apparel</p></li></ul> Feb 18th, 2022 02:15AM Feb 18th, 2022 02:15AM Jazz Pharmaceuticals Health Care Pharmaceuticals & Biotechnology

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