Clinical Trial Manager
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What you'll do
- Lead the operational execution of assigned domestic or global early phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
- Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
- Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
- Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
- Manage clinical development vendors according to vendor oversight plans.
- Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
- Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
- Prepares and/or reviews study-related study plans/documents; reviews site study documents.
- May assist in strategic trial design and protocol writing and reviewing / contributing to clinical regulatory documents to support upcoming programs (regulatory submissions, clinical overviews, pediatric study plans, etc.).
- Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
- Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
- Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
What they're looking for
- Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
- 10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO), pharmaceutical/biotechnology company, or clinical research environment (e.g., CRA, site coordinator, drug safety specialist, regulatory-clinical specialist), including 5+ years of clinical project/trial management (PM) or equivalent clinical operations experience.
- Knowledge of international regulatory requirements (FDA, EMA, GCP, GMP, GDPR).
- Experience in and knowledge of the pharmaceutical development process
Nice to have
- 5+ years’ experience of clinical trial management for early phase studies conducted in the US and India
- Broad understanding of regulatory GMP requirements for IMP product packaging and supply
- Excellent organizational and leadership skills.
- Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
About the Role:
The Clinical Trial Manager is responsible for leading the planning, execution, oversight, and delivery of early phase clinical trials. The CPM serves as the operational leader for assigned studies, partnering cross-functionally with the Clinical Development Lead / Clinical Scientist, Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, within budget, and in compliance with applicable regulations and quality standards.
Key Responsibilities
- Lead the operational execution of assigned domestic or global early phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability, quality, and on time delivery of key project deliverables.
- Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met.
- Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors, bioanalytical vendors, etc.
- Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics, and Quality to oversee CRO vendors and ensure study excellence.
- Manage clinical development vendors according to vendor oversight plans.
- Oversee all study-level data monitoring activities, reviews monitoring visit reports, and conducts Sponsor oversight monitoring visits as required.
- Responsible for monthly Protocol Deviation (PD) review, including oversight of CRA documentation and collaboration with Medical Monitor for medical review.
- Prepares and/or reviews study-related study plans/documents; reviews site study documents.
- May assist in strategic trial design and protocol writing and reviewing / contributing to clinical regulatory documents to support upcoming programs (regulatory submissions, clinical overviews, pediatric study plans, etc.).
- Strategic country/site selection with program input and ensuring consistency across all clinical projects for therapeutic area.
- Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files, Trial Master File (TMF), and clinical trial registry submissions.
- Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
Required Skills and Experience
- Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
- 10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO), pharmaceutical/biotechnology company, or clinical research environment (e.g., CRA, site coordinator, drug safety specialist, regulatory-clinical specialist), including 5+ years of clinical project/trial management (PM) or equivalent clinical operations experience.
- Knowledge of international regulatory requirements (FDA, EMA, GCP, GMP, GDPR).
- Experience in and knowledge of the pharmaceutical development process
Preferred Qualifications
- 5+ years’ experience of clinical trial management for early phase studies conducted in the US and India
- Broad understanding of regulatory GMP requirements for IMP product packaging and supply
- Excellent organizational and leadership skills.
- Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments.
By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.
Company
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