What are the responsibilities and job description for the Late Phase Research Project Manager position at Careers Integrated Resources Inc?
Job Title: Late Phase Research Project Manager
Location: Cambridge, MA*Onsite
Contract: 10 Months (Possibility of Extension)
Pay Range: $60/Hr. on W2
Job Duties:
Duties include, but are not limited to:
Education:
Languages:
Skills:
Location: Cambridge, MA*Onsite
Contract: 10 Months (Possibility of Extension)
Pay Range: $60/Hr. on W2
Job Duties:
- We are seeking a highly experienced, organized, and motivated Clinical Study Manager (CSM) to join our dynamic Global Medical Affairs Operations team.
- This pivotal role will oversee late-phase, non-interventional studies and support the execution of medical affairs-driven research initiatives.
- Reporting to the Associate Director, Medical Program Management, the CSM will collaborate with Medical Strategy leadership, ensuring operational excellence in study management while contributing to broader medical affairs projects.
- The ideal candidate will possess extensive expertise in late-phase study management and operational oversight, with a strong background in program/project management and cross-functional collaboration within the biotechnology or pharmaceutical industry.
Duties include, but are not limited to:
- Provide day-to-day operational oversight and management for late-phase, non-interventional studies, ensuring compliance with regulatory, ethical, and organizational standards.
- Collaborate with cross-functional teams (medical, regulatory, legal, and compliance) to drive study progress, manage deliverables, and resolve operational challenges.
- Develop and manage study timelines, budgets, and resource allocation, ensuring alignment with organizational goals.
- Support protocol development, vendor selection and oversight, and study-specific operational plans.
- Monitor study progress, generate status reports, and communicate key updates to stakeholders, ensuring proactive resolution of potential roadblocks.
- Oversee the collection, review, and submission of study documents to ensure audit readiness and compliance with SOPs and regulatory requirements.
- Partner with Medical Strategy leadership to identify and address strategic priorities in late-phase research, contributing to broader medical affairs initiatives.
- Assist in the development and implementation of medical affairs processes, global planning templates, and operational best practices.
- Support operational and project management activities for other key medical affairs initiatives, including advisory boards, medical education programs, and engagement activities.
Education:
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or related field (advanced degree preferred).
Languages:
- English( Speak, Read, Write )
Skills:
- 5 years in clinical study management, with a focus on late-phase and non-interventional studies within biotechnology or pharmaceutical industries. Additional project management experience preferred.
Salary : $60
