Clinical Project Manager

Sun Pharma - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

Health and Personal Care Retailers

About the position

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.

Responsibilities

• Lead pivotal development programs within clinical research.
• Mentor, motivate, train, and oversee a team of Project Managers, CRAs, and CTAs.
• Oversee and 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 regulatory submissions.
• Manage and assess vendor performance regarding timelines and deliverables.
• Prepare and review budgets for studies managed in-house and review costs for CROs and vendors.
• Support the Functional Head in preparing annual studies and department budgets.
• Manage and track study budgets, project milestones, and timelines throughout the study lifecycle.
• Plan study activities and timelines, sharing with stakeholders and setting up tracking tools.
• Coordinate finalization of IP labels and requisition, and forecast IP requirements.
• Prepare and review study plans for in-house and outsourced studies.
• Train study team on trial documents, processes, and assigned SOPs.
• Facilitate vendor kick-off meetings and investigator meetings for studies.
• Drive subject recruitment for assigned studies and meet predefined timelines.
• Implement quality control plans for assigned studies and ensure compliance with regulations.
• Coordinate with cross-functional groups for required deliverables.

Requirements

• Proven experience in managing clinical trials from phase I to IV.
• Strong leadership skills with experience in team mentoring and training.
• In-depth knowledge of clinical trial processes and regulations (ICH-GCP, SOPs).
• Experience in budget preparation and management for clinical studies.
• Ability to manage vendor relationships and assess performance effectively.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent communication skills for liaising with internal and external stakeholders.

Nice-to-haves

• Experience with global clinical trials is a plus.
• Familiarity with electronic data capture systems and clinical trial management software.
• Previous experience in a CRO or pharmaceutical company.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid time off and holidays.
• Professional development opportunities.
• Flexible working hours.