Project Manager, Central Labs

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll join a global organization at the forefront of clinical research and laboratory science. In partnership with PPD, we support the world’s leading pharmaceutical and biotech organizations—successfully delivering over 2,700 clinical trials across 100+ countries in the past five years. We are seeking a Project Manager, Central Labs to lead and coordinate central laboratory activities across clinical trial programs. This is a high-impact role requiring strong operational oversight, cross-functional leadership, and client engagement. This is a fully remote role supporting our Global Central Laboratories. We welcome applicants from all locations within the US.  Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

Overview The Project Manager, Central Labs monitors and manages all aspects of designated clinical trial protocols in Global Central Labs and is accountable for overall project performance and client’s satisfaction by meeting their needs and expectations through the life cycle of the assigned clinical trials. The Project Manager provides internal consulting on project management issues, identifies opportunities for process and efficiency improvement, acts as chief liaison to the operational personnel of major sponsors, and is responsible for large study programs. Additionally, the Project Manager prepares and maintains process documents and mentors Project Managers.

Responsibilities: Provide oversight and coordination of study initiation. Review, interpret, translate and program study protocols into a complete and accurate database. Communicate with internal departments and external vendors to ensure project requirements are understood, agreed upon, and followed at all times. Facilitate the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel). Consult and utilize, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial. Prepare study specification documents and follow their preparation according to budgets and contracts. Maintain at all times an updated study master file with version controls for specifications, budgets, and contracts. Ensure sponsors have authorized and signed off on the most recent versions of all documents and that a contract exists prior to delivering any services. Assure compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens. During the initial review of the protocol, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent protocol amendments. Obtain other functions’ commitment to close gaps and address issues timely and effectively. Serve as chief liaison between the sponsor and all PPD internal departments performing the required tasks during all study phases. Educate Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meeting. Control, manage, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries. Actively consult with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities. Consult with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments. Advise on possible solutions if needed. Draft responses for proposals. Guide and