Clinical Trial Manager

Azurity Pharmaceuticals; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Clinical Trial Manager to lead planning, execution, and delivery of early phase 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.

Qualifications

• Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
• 10+ years experience in pharma/biotech CRO or clinical research, including 5+ years in PM/clinical operations.
• Knowledge of FDA, EMA, GCP, GMP, GDPR.
• Understanding of international regulatory requirements.

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.
• 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.

Skills

Regulatory compliance

Clinical trial management

Vendor management

Education

Bachelor's degree in Life Sciences

Job description

Job Summary

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.

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

• Bachelors 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.