Sun Pharma - Princeton, NJ
posted 2 months ago
The position involves leading pivotal development programs within the clinical research domain, specifically overseeing and managing all operational aspects of phase I-IV clinical trials, which may be US-based or global in nature. The role requires a strong focus on team mentoring, motivating, training, and providing oversight for a team that includes Project Managers, Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs). As the primary point of contact for both internal and external teams, the individual will be responsible for the planning, conduct, and reporting of assigned trials, ensuring that all operational activities align with the strategic goals of the organization. In addition to managing trial operations, the position entails participating in the vendor selection process alongside an assigned PMO representative. This includes developing proposals, engaging in the bid-defense process, and conducting thorough contract reviews. The individual will oversee study start-up activities conducted by Contract Research Organizations (CROs), which encompass site identification, feasibility assessments, site selection, contract negotiations, and the finalization of Clinical Study Agreements. The role also requires the oversight of vendor performance, ensuring that timelines and deliverables are met effectively. Budget management is another critical aspect of this position. The individual will prepare and review budgets for studies managed in-house, as well as review professional fees and pass-through costs associated with CROs, Site Management Organizations (SMOs), investigators, and other vendors. They will support the Functional Head in preparing the annual studies budget and department budget, while also managing and tracking study budgets, project milestones, and timelines throughout the study lifecycle. This includes performing contract reconciliations at the study's conclusion. The role requires planning study activities and timelines, sharing these with stakeholders, and setting up tracking tools to assess progress against pre-set timelines. The individual will coordinate the finalization of Investigational Product (IP) labels and requisitions, forecast IP requirements during the study, and prepare IP requisitions accordingly. Additionally, they will prepare and review study plans for both in-house and outsourced studies, train the study team on trial documents, processes, and assigned Standard Operating Procedures (SOPs), and facilitate vendor kick-off meetings and investigator meetings for the studies. Engaging with investigators and key opinion leaders is essential for driving subject recruitment and meeting predefined timelines. Finally, the individual will implement quality control plans for assigned studies, ensuring compliance with ICH-GCP, SOPs, and applicable regulations, while coordinating with cross-functional groups for required deliverables.