Clinical Project Manager

Overview

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, commercial products

Experience: Min 3–5+ years

Education: Min. Bachelors; MS or PhD are ok

Soft skills: Excellent verbal and written communication; ability to work independently

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 management
• Track IIS/RC metrics and provide regular updates to Medical Affairs leadership
• Ensure inspection 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 efficiencies
• 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
• Excellent verbal and written communication skills
• Strong relationship-building and stakeholder management capabilities
• Highly organized, detail-oriented, and able to work independently
• Solution-oriented mindset with strong problem-solving skills