Associate Director, Clinical Operations

Sun Pharmaceutical Industries - Princeton, NJ

Full-time

Princeton, NJ

Chemical Manufacturing

About the position

The Associate Director, Clinical Operations at Sun Pharmaceutical Industries, Inc. is a pivotal role responsible for overseeing the Project Management team, Clinical Research Associates, and Clinical Trial Associates. This hybrid position is based in Princeton, New Jersey, and requires a strong leader who can motivate, mentor, and train team members effectively. The Associate Director will manage all operational aspects of phase I-IV clinical trials, whether they are US-based or global in scope. This includes acting as the primary point of contact for both internal and external teams throughout the planning, conduct, and reporting phases of assigned trials. In this role, the Associate Director will participate in the vendor selection process alongside the assigned PMO representative, which encompasses proposal development, the bid-defense process, and contract review. They will oversee study start-up activities conducted by Contract Research Organizations (CROs), which include site identification, feasibility assessments, site selection, contract negotiations, and the finalization of Clinical Study Agreements. Additionally, the Associate Director will manage and assess vendor performance, ensuring that timelines and deliverables are met. The position also involves budget management, where the Associate Director will prepare and review budgets for studies managed in-house, as well as review professional fees and pass-through costs for CROs, Site Management Organizations (SMOs), investigators, and vendors. They will support the Functional Head in preparing the annual studies budget and department budget, while also tracking study budgets, project milestones, and timelines throughout the study lifecycle. The Associate Director will be responsible for planning study activities, coordinating with stakeholders, and setting up tracking tools to assess progress against pre-set timelines. Moreover, the Associate Director will facilitate vendor kick-off meetings and Investigator Meetings, drive subject recruitment for assigned studies, and ensure compliance with ICH-GCP, SOPs, and applicable regulations through the implementation of quality control plans. They will also oversee the maintenance and timely updates of the Trial Master File (TMF/eTMF) and study folders, review study-specific documents, and perform co-monitoring and vendor oversight visits to ensure the quality of trial conduct. This role requires a proactive approach to lead process initiatives and improvements as assigned by the function head, contributing to the development and finalization of key study documents, and ensuring the closure of in-house trials after all planned activities are completed.

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 team 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 fee and pass through costs for CROs, SMOs, investigators, and vendors.
• Support Functional Head in preparation of annual studies budget and department budget.
• 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.
• Coordinate finalization of investigational product (IP) label and requisition, forecasting IP requirements during the study.
• Prepare/review study plans for in-house/outsourced studies and 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 plan in assigned studies to ensure compliance with ICH-GCP, SOPs, and applicable regulations.
• Coordinate with cross functional groups for required deliverables.
• Oversee maintenance and timely update of Trial Master File (TMF/eTMF) and study folder, tracking study information.
• Review study specific documents including status reports, site visit reports, and study plans to 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.
• Complete assigned trainings and maintain an updated personal training file.

Requirements

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