Job Title: Late Phase Research Project Manager

Location: Cambridge, MA

We are seeking an experienced and motivated Clinical Study Manager (CSM) to join our Global Medical Affairs Operations team. This role will oversee late-phase, non-interventional studies and support the execution of medical affairs-driven research initiatives. The CSM will collaborate with Medical Strategy leadership, ensuring operational excellence in study management while contributing to broader medical affairs projects.

Key Responsibilities:

• Provide operational oversight for late-phase, non-interventional studies, ensuring compliance with regulatory, ethical, and organizational standards.
• Collaborate with cross-functional teams (medical, regulatory, legal, compliance) to drive study progress, manage deliverables, and resolve challenges.
• Develop and manage study timelines, budgets, and resource allocation, ensuring alignment with organizational goals.
• Support protocol development, vendor selection, and study-specific operational plans.
• Monitor study progress, generate status reports, and communicate key updates to stakeholders.
• Ensure audit readiness and compliance with SOPs and regulatory requirements.
• Contribute to strategic priorities in late-phase research and broader medical affairs initiatives.
• Support operational activities for other key medical affairs initiatives, including advisory boards and medical education programs.

Qualifications:

• 5+ years in clinical study management, with a focus on late-phase and non-interventional studies within biotech or pharma.
• Project management experience preferred.
• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or related field (advanced degree preferred).

Contract Details:

• Duration: 6 months
• Location: Cambridge, MA
• Work Authorization: Green Card, US Citizen
• Pay Range: $60.00 - $65.00/hour