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Ardelyx

- NASDAQ:ARDX
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# Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
1 nasdaq:ardx www.ardelyx.com www.ardelyx.com Feb 15th, 2019 12:00AM Quality Assurance Specialist III (Analytical) Open Quality Assurance Fremont, CA, United States Fremont CA USA Jan 11th, 2019 12:00AM Quality Assurance Specialist III (Analytical) Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease who are on dialysis and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a New Drug Application to the U.S. Food and Drug Administration seeking U.S. marketing approval for this indication. To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Hakko Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. The QA Specialist III (Analytical) will provide QA support for Quality Operations and Quality System management. Working in a fast -paced pharmaceutical environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA Analytical activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to perform batch records review and product dispositions, to implement sound Quality System improvements and manage QA procedures, assess GMP suppliers and service providers. In addition, the position requires someone with strong skills in document management and change control procedures and deviations and CAPA processes in a GMP, GCP and GLP regulated environment. Position Responsibilities: Participate in the review of analytical methods, method validation protocols and reports including revisions and associated change controlsParticipate in the review of specifications, including justifications for specifications and subsequent revisions to specificationsLiaise with Regulatory Affairs on any method/specification changes that may impact regulatory filingsReview all the supporting documents regarding Quality System documentation including deviations (such as OOS), CAPAs, and change controlsReview stability protocol per internal procedure, ICH or post approval commitment requirementsReview and approve stability data generated internally or externally (including identification of trend)Review and approve COA and associated raw data from CMO to ensure that they are accurate and completeReview SOPs, Manufacturing records, forms, quality control records, and documents related to analytical activitiesSupport QA CMO oversight activities to ensure required quality standards are maintainedCollaborate with Manufacturing and Analytical Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve minor and major deviationsSupport cGMP compliance audits of GxP suppliers’ quality systemsSupport Document Control related processesSupport and conduct training for employees, as necessarySupport the analysis and reporting of product and process quality trends, and quality system performance against internal and external guidelines, standards and regulationsPerform other related duties as assigned from time to time based on company needs Position Requirements: Bachelors’ or higher degree in sciences5+ years of analytical experience in a biotechnology or pharmaceutical industries (Method development, method validation/verification, method transfer, data review and approval, OOS investigation, protocol design)3+ years’ experience in a GMP environmentSome experience in manufacturing of drug substances or drug products a plusExtensive knowledge of GMP regulations and guidance (such as US, EU, and ICH)Extensive experience with Quality Assurance systems and processesEffective organization and planning skillsDemonstrated ability to deal with frequent changes, delays or unexpected eventsStrong technical writing skillsAdvanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Veeva (a plus)) and demonstrated troubleshooting and problem-solving techniquesStrategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groupsProven ability to work under tight deadlines and pressure in a composed mannerEffective interpersonal and communication skillsStrong team playerComfortable communicating with all levels of staff, including executives As a member of the Ardelyx team, you will help us in developing and bringing to market first in class medicines to better the lives of underserved patients with cardiorenal diseases. It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture.. Ardelyx, Inc. is an Equal Opportunity Employer. Feb 14th, 2019 09:22PM Feb 14th, 2019 09:22PM Health Care Pharmaceuticals & Biotechnology
2 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 9th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 9th, 2018 12:13AM Aug 9th, 2018 12:13AM Health Care Pharmaceuticals & Biotechnology
3 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 8th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 7th, 2018 10:35PM Aug 7th, 2018 10:35PM Health Care Pharmaceuticals & Biotechnology
4 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 7th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 6th, 2018 10:50PM Aug 6th, 2018 10:50PM Health Care Pharmaceuticals & Biotechnology
5 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 6th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 5th, 2018 10:32PM Aug 5th, 2018 10:32PM Health Care Pharmaceuticals & Biotechnology
6 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 5th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 4th, 2018 10:32PM Aug 4th, 2018 10:32PM Health Care Pharmaceuticals & Biotechnology
7 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 4th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 3rd, 2018 10:31PM Aug 3rd, 2018 10:31PM Health Care Pharmaceuticals & Biotechnology
8 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 3rd, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 2nd, 2018 10:33PM Aug 2nd, 2018 10:33PM Health Care Pharmaceuticals & Biotechnology
9 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 2nd, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Aug 1st, 2018 10:29PM Aug 1st, 2018 10:29PM Health Care Pharmaceuticals & Biotechnology
10 nasdaq:ardx www.ardelyx.com www.ardelyx.com Aug 1st, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials) Open Clinical Fremont, CA, United States Fremont CA USA Jun 27th, 2018 12:00AM CTM Clinical Project Manager (Clinical Trials)Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.We are currently seeking a Clinical Project Manager to join the Ardelyx.     This person will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. The position can be based at our HQ in Fremont, California or Waltham, Massachusetts. Contractor option can also be considered. Position Responsibilities: Responsible for the preparation and finalization of project and study-related documents that may include: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.Participate in the selection of investigators and study sites.Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT and file/edit study documents in eTMF.Ensure that CRF data queries are resolved.Coordinate and manage Investigational Product including overall accountability and reconciliation Work with Clinical Operations team for the preparation of study budgets and timelines.Manage project timelines and vendor performance to meet departmental and corporate goals.Monitor and track clinical trial progress and provide status update reports.Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).Represent Clinical Operations at the Project Team level for individual studies, as appropriate.Partner with other research and development groups to achieve deliverables.Participate in Site Initiation Visits (SIVs) as required.Co-Monitoring of regional sites for adherence to protocol and GCP as required.Travel as required to carry out responsibilities.Identify and escalate site, vendor and study related issues to supervisor, as appropriate.Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner.Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals and perform other duties as assigned. Position Requirements: BA/BS/MS in a scientific discipline.7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience).Must have demonstrated expertise in relevant clinical operations activities.Knowledge of ICH/GCP guidelines and FDA regulations.Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.Good organization and planning skillsStrong interpersonal skills and communication skills (both written and oral).Ability to problem solve and delegate appropriate tasks to subordinates.Strong leadership skills, self-motivated, adaptable to a dynamic environment.Able to collaborate effectively with the study team, cross-functional team members, and external partners.Proficiency in MS Word, Excel and PowerPoint.Able and willing to travel approximately 10-20%.We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world-class research.  Ardelyx offers a competitive total rewards package, perks and an innovative, dynamic culture and research environment.Ardelyx, Inc. is an Equal Opportunity Employer. Jul 31st, 2018 10:29PM Jul 31st, 2018 10:29PM Health Care Pharmaceuticals & Biotechnology

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