What are the responsibilities and job description for the Late Phase Research Project Manager position at Tundra Technical Solutions?
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
Salary : $60 - $65
