Sun Pharma - Princeton, NJ
posted 2 months ago
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.