Associate Director, Clinical Operations

Sun Pharmaceutical Industries - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

Chemical Manufacturing

About the position

The Associate Director, Clinical Operations is responsible for overseeing the Project Management team, Clinical Research Associates, and Clinical Trial Associates. This hybrid role, based in Princeton, New Jersey, focuses on managing all operational aspects of clinical trials, ensuring compliance with regulations, and driving the success of studies from initiation to closure.

Responsibilities

• Oversee and manage all operational aspects of phase I-IV US-based or global clinical trials.
• Act as primary point of contact for internal and external teams for planning, conduct, and reporting of assigned trials.
• Participate in vendor selection process with assigned PMO representative, including proposal development, bid-defense process, and contract review.
• Oversee study start-up activities of CROs, including site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization.
• Manage and assess vendor performance regarding timelines and deliverables.
• Develop team and process for carrying out start-up activities for faster first patient in (FPI) in global or US-only studies.
• Prepare/review budgets for studies managed in-house and review professional fees and pass-through costs for CROs, SMOs, investigators, and vendors.
• Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end.
• Plan study activities and timelines, share with stakeholders, and set up tracking tools for assigned trials.
• Train study team on trial documents, processes, and assigned SOPs.
• Plan and facilitate vendor kick-off meetings and investigator meetings for studies.
• Drive subject recruitment for assigned studies and meet predefined timelines.
• Prepare and implement quality control plans in assigned studies to ensure compliance with ICH-GCP, SOPs, and applicable regulations.
• Coordinate with cross-functional groups for required deliverables and oversee maintenance of Trial Master File (TMF/eTMF).
• Review study-specific documents including status reports, site visit reports, and ensure quality in the study.
• Perform co-monitoring and vendor oversight visits to ensure quality of trial conduct.
• Provide status updates to stakeholders as per project requirements.
• Lead process initiatives and improvements as assigned by the function head.
• Contribute to development and finalization of key study documents such as protocols and informed consent documents.
• Ensure in-house trial closure after completion of all planned activities and oversee archival of all study documents.

Requirements

• Bachelor's degree in life sciences.
• 7-10 years of clinical trial experience.