Director, Clinical Operations

Sun Pharma - Princeton, NJ

Full-time - Senior

Princeton, NJ

Health and Personal Care Retailers

About the position

The Director of Clinical Operations/CPM at Sun Pharma Advanced Research Company, Limited is a pivotal role responsible for the establishment and development of a Clinical Operations Team in the United States. This position requires a strategic leader who will work closely with the Function Head in resource planning and assignments across various clinical studies. The Director will be tasked with mentoring, motivating, training, and overseeing a team of Project Managers, Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs). The role encompasses the management of all operational aspects of phase I-IV clinical trials, whether they are US-based or global in nature. As the primary point of contact for both internal and external teams, the Director will oversee the planning, conduct, and reporting of assigned trials. This includes participating in the vendor selection process alongside the assigned PMO representative, which involves proposal development, bid-defense processes, and contract reviews. The Director will also manage 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. In addition to operational oversight, the Director will be responsible for budget preparation and review for studies managed in-house, as well as tracking study budgets, project milestones, and timelines throughout the study lifecycle. This role requires the ability to forecast investigational product (IP) requirements, prepare requisitions, and ensure compliance with ICH-GCP, SOPs, and applicable regulations. The Director will also lead quality control initiatives, coordinate with cross-functional groups, and ensure the timely maintenance and update of the Trial Master File (TMF/eTMF). The position also involves line management responsibilities, including performance appraisals for assigned resources, and participation in audits and assessments. The Director will contribute to the development of key study documents and ensure the closure of in-house trials after all planned activities are completed. This role is essential for driving subject recruitment, meeting predefined timelines, and ensuring the overall quality of clinical trials.

Responsibilities

• Develop and lead a Clinical Operations Team in the United States.
• Mentor, motivate, train, and oversee a team of Project Managers, CRAs, and CTAs.
• Manage all operational aspects of phase I-IV clinical trials.
• Act as the primary point of contact for internal and external teams for assigned trials.
• Participate in the vendor selection process, including proposal development and contract review.
• Oversee study start-up activities of CROs, including site identification and feasibility assessments.
• Prepare and review budgets for studies managed in-house and track study budgets throughout the lifecycle.
• Plan study activities and timelines, sharing updates with stakeholders.
• Coordinate finalization of investigational product labels and requisitions.
• Prepare and review study plans for in-house and outsourced studies.
• Train study teams on trial documents, processes, and assigned SOPs.
• Facilitate vendor kick-off meetings and investigator meetings for studies.
• Drive subject recruitment for assigned studies and ensure compliance with timelines.
• Implement quality control plans and ensure compliance with ICH-GCP and applicable regulations.
• Oversee maintenance and timely updates of the Trial Master File (TMF/eTMF).
• Review study-specific documents 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 required.
• Lead process initiatives and improvements as assigned by the function head.
• Contribute to the development and finalization of key study documents.
• Ensure in-house trial closure and oversee archival of all study documents.
• Manage line management responsibilities, including performance appraisal for assigned resources.

Requirements

• Bachelor of Science in a life sciences discipline or higher qualification.
• 10+ years of clinical trial experience.