Labs Project Manager

Thermo Fisher Scientific • Highland Heights, KY

16h • Remote

About The Position

The Project Manager, Central Labs leads and coordinates central laboratory activities across clinical trial programs. This role monitors and manages designated clinical trial protocols in Global Central Labs and is accountable for overall project performance and client satisfaction throughout each trial’s lifecycle. The Project Manager provides internal project-management consulting, identifies process and efficiency improvements, serves as the primary liaison to operational personnel at major sponsors, and oversees large study programs. The role also maintains process documents and mentors Project Managers.

This is a fully remote position supporting Global Central Laboratories, open to applicants anywhere in the United States. Applicants must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. The position follows a standard Monday–Friday schedule and may require travel.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years, or an equivalent combination of education, training, and experience.
• Strong verbal, written, and presentation skills.
• Superior time-management, planning, and organizational skills.
• Competence with specific computers and enterprise applications, including office productivity software.
• Ability to program the IT system according to protocol requirements.
• Proven analytical skills.
• Demonstrated compliance with procedures and policies.
• Ability to perform multiple tasks effectively in a stressful environment.
• Extensive knowledge and experience in project management in a Global Central Lab environment.
• Strong client relationship management skills.
• Ability to work effectively with multi-level teams.
• Legally authorized to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Responsibilities

• Provide oversight and coordinate study initiation.
• Review, interpret, translate, and program study protocols into a complete and accurate database.
• Coordinate with internal departments and external vendors to ensure project requirements are understood, agreed upon, and followed.
• Facilitate the flow of technical and clinical laboratory information to investigational sites, sponsors, and non-technical personnel.
• Consult laboratory management and technical staff for scientific input to support clients in managing clinical trials.
• Prepare study specification documents and ensure their preparation follows budgets and contracts.
• Maintain an updated study master file, including version control for specifications, budgets, and contracts.
• Ensure sponsors authorize and sign off on the latest document versions and that a contract is in place before services are delivered.
• Ensure compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, the PPD Exposure Control Plan, IATA, and other regulations concerning biological specimen transport.
• Consult internal groups and support staff during initial protocol review on procedural and budgetary matters, including changes required by protocol amendments.
• Obtain cross-functional commitments to close gaps and address issues promptly and effectively.
• Serve as the primary liaison between sponsors and PPD internal departments throughout all study phases.
• Educate investigator sites by presenting and demonstrating protocol-specific laboratory procedures at investigator meetings.
• Manage and monitor day-to-day clinical trial activities, resolving issues and answering queries.
• Consult IT and data management development groups on the design, validation, and implementation of software and functionality related to project management.
• Consult business development and finance staff on standard services and costs during initial project documentation review, and support RFP feasibility assessments.
• Advise on potential solutions and draft proposal responses.
• Guide and support Project Managers and Set-up Administrators, with particular attention to training junior personnel.
• Mentor and train newly assigned Project Managers, identify development and efficiency opportunities, and author, review, revise, and implement relevant procedural documents.
• Serve as backup for the Associate Director PM when needed.

Benefits

• Employee health and wellbeing support, including encouragement to create a healthy and balanced environment.
• Accessibility assistance and accommodations for job seekers during the application process.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level