Job Description: Project Manager/Clinical Study Manager

Position Overview

At Thermo Fisher Scientific, we are seeking a Project Manager/Clinical Study Manager to join our Functional Service Provider Team. This role is crucial for directing, coordinating, and managing the technical and operational aspects of clinical trials, ensuring their successful completion. You will collaborate with functional area leads to identify and resolve project issues, contributing to the delivery of life-changing therapies. This position offers the opportunity to engage in diverse initiatives, work on global projects, and gain cross-cultural experience.

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Location Type: Remote (North America region)
• Hiring Level: Project Manager/Clinical Study Manager (depending on experience)

Key Responsibilities

The Project Manager/Clinical Study Manager is accountable for the overall delivery of the project, encompassing quality, time, and cost.

• Project Leadership:
  • Lead cross-functional project teams to meet or exceed deliverables.
  • Manage projects of increasing complexity (multi-service, multi-region/country, therapeutic complexity, financial scope).
  • Drive and own the overall delivery of the cross-functional project (time, cost, quality).
• Study Execution & Strategy:
  • Lead or support study operational strategy and planning.
  • Oversee the execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting the clinical strategy defined in the Clinical Development Plan.
  • Support or oversee the execution of select study/ies in compliance with quality standards (including ICH GCP, local regulations, and SOPs), on schedule, and on budget.
• Client & Stakeholder Management:
  • Serve as the primary contact and lead between the sponsor and the organization at the project level.
  • Establish and communicate customer expectations to the project team with minimal direction.
  • Ensure that escalation pathways are adhered to internally and externally.
• Vendor & Partner Management:
  • Oversee Strategic Partners and/or other CROs and vendors to meet sponsor obligations and business objectives.
  • Oversee Strategic Partner/CRO/vendor selection, budget, and contract negotiation.
  • Supervise the performance of all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalating issues to governance committees when warranted.
• Financial Management:
  • Support/review study budget planning and management.
  • Be accountable for external spend related to study execution.
  • Work closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure accuracy of budgets, enrollment, and gating.
  • Ensure financial stewardship at a project level by understanding the contract, managing resource alignment to budget, handling Out of Scope activities, and driving the Change Order process/negotiations and team execution to timelines.
• Communication & Escalation:
  • Communicate study status, costs, and issues to COM and COPL.
  • Serve as an escalation point for all vendors managed by Strategic Partners and/or other CROs.

Company Information

At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our Project Delivery colleagues within our PPD® clinical research services play a vital role in helping our customers deliver life-changing therapies.