Project Manager, FSP

Thermo Fisher Scientific

full-time

Posted on: 9/26/2025

Location: North Carolina • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s)
Support or oversee the execution of select complex study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget
Oversee Strategic Partners and/or other CROs and other vendors to meet Takeda’s obligations
Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
Support budget development and ensure impacts are adequately addressed
Participate in country and site feasibility/selection process
Develop and manage study timelines
Ensure new team members and vendors are appropriately onboarded
Identify and oversee trial risk and mitigation
Leader of the cross functional study team
Lead development of the Operational Strategy in preparation for Operational Strategy Review with Strategic Partners/CROs
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
Support/review study budget planning and management and accountable for external spend related to study execution
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance
Review and approval of key monitoring documents/plans, periodic review of outputs
Conduct Oversight Monitoring Visits, as applicable
Review and endorsement of relevant study plans and team meeting management
Review of outcomes/actions related to protocol deviations and trend identification
Documented review and monitoring of issues, risks and decisions at the study level
Review and ownership of trial operational data (e.g. CTMS)
Review and provide oversight of internal trial reports
In partnership with data management, review and pressure test all database timelines and plans
Support data review for database lock and CSR writing and review
Collect/review/File study documents in support of the TMF and regulatory filing
Responsible for overseeing study financial reconciliation
Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections
Site relationship management and oversight of trial audits
Preparation for Agency inspections, including document readiness and tracking

Requirements

MUST HAVE 4+ YEARS OF GLOBAL LEAD PM EXPERIENCE
MUST HAVE STRONG VENDOR MANAGEMENT EXPERIENCE
MUST BE ABLE TO WORK WELL UNDER PRESSURE FOR HIGH VISIBILITY STUDY
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
Awareness of local country requirements
Demonstrated successful experience in project/program management and matrix leadership
Works independently and is highly organized
Good communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Demonstrated successful experience managing recruitment challenges and boosting enrollment
Fluent business English (oral and written)
6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight
Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
Experience in more than one therapeutic area is advantageous
Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience may be considered to supplement experience requirements

Project Manager, FSP

Job Level

Tech Stack

About the role

Requirements

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