Clinical Research Project Manager

Title:

Senior Manager, Clinical Research

Location:

Cambridge, MA (HYBRID) Duration: 6 months (coverage for leave)

NOTE:

start: early March – April 1 latest.

• SR PM to Manage and oversee investigator-initiated studies (IIS/ISS) and research collaborations, including externally sponsored research.
• Standard EST business hours, no weekend work.
• Tools:
  Ariba, SharePoint.
• Ariba for POs, invoices, agreements, SharePoint, legal contracting tools

• Experience managing and running investigator-initiated studies and research collaborations;
  External sponsored research exp.
• Ability to keep track of various projects that are all in different phases.
• Senior project management in clinical trials/research studies.
• Overseeing research study operations.
• Role will focus on Phase 4 clinical trials and commercial products.
• Experience:
  
  Min 3–5+ years
• Education:
  
  Min. Bachelors; MS or PhD are ok

• The Senior Manager, Medical Research - IIS & Research Collaborations plays a key role in advancing externally sponsored research initiatives.
• In this position, you will lead the operational execution and oversight of Investigator Initiated Studies (IIS) and Research Collaborations (RC), working closely with cross-functional teams to ensure efficient study execution.
• You will serve as a central point of contact for investigators, internal teams, and vendors, ensuring high-quality execution and oversight of the externally sponsored research.
• This role is ideal for a detail-oriented, relationship-driven scientific operations professional who thrives in a fast-moving, global environment.
• Serve as the primary point of contact for IIS and RC activities across regions.
• Manage communications and relationships with investigators, academic partners, and internal stakeholders.
• Oversee the full lifecycle of externally sponsored research, including concept intake, review, budget approval, contracting, study execution, and close‑out.
• Coordinate Medical Affairs Review Board (MARB) meetings, including agenda development, document preparation, and minutes of management.
• Track IIS/RC metrics and provide regular updates to Medical Affairs leadership.
• Ensure inspection of readiness through complete, accurate, and readily retrievable documentation.
• Partner with GPSRM and QA to support audits and inspections.
• Provide oversight and collaborate with IIS portal vendor on issues and updates.
• Accountable for ensuring drug shipment activities comply with local/regional requirements and Client quality standards.
• Management of IIS and RC budgets, including annual budget planning.
• Proactively identify operational challenges and propose practical solutions.
• Contribute to initiatives aimed at improving investigator experience and internal efficiency.
• Uphold and model Client Core Values in every aspect of work

• BA/BS in Life Sciences or related field is required
• Advanced degree or certification preferred.
• Proven experience in the pharmaceutical/biotech industry, prior experience in Clinical Operations and/or Medical Affairs supporting GCP/GPP studies.
• Experience managing externally sponsored research (IIS/RC) strongly preferred.
• Strong working knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
• Strong relationship-building and stakeholder management capabilities.