Labs Project Manager

Thermo Fisher Scientific • Highland Heights, KY

2d • Remote

About The Position

Thermo Fisher Scientific is seeking a Project Manager, Labs to lead and coordinate central laboratory activities across clinical trial programs. The role monitors and manages all aspects of designated clinical trial protocols in Global Central Labs, with accountability for 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 principal liaison to major sponsors’ operational personnel, and is responsible for large study programs. The role also prepares and maintains process documents and mentors Project Managers.

This is a fully remote role supporting Global Central Laboratories, open to applicants located 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 work schedule is standard Monday through Friday, in an office-work context. Travel may be required; the recruiter will provide more details.

Requirements

• Bachelor’s degree or equivalent, plus a relevant formal academic or vocational qualification.
• At least 2 years of comparable previous experience, or an equivalent combination of education, training, and experience.
• Strong verbal, written, and presentation skills.
• Superior time-management, planning, and organizational skills.
• Competence with computers and enterprise applications, including office productivity tools.
• 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.
• Must be legally authorized to work in the United States without sponsorship.
• Must pass a comprehensive background check, including drug screening.

Responsibilities

• Oversee and coordinate study initiation; review, interpret, translate, and program study protocols into complete and accurate databases.
• Communicate 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 to support clients.
• Prepare study specification documents in accordance with budgets and contracts, and maintain an updated study master file with version control for specifications, budgets, and contracts.
• Ensure sponsors authorize and sign off on current document versions and that contracts are 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 for biological specimen transport.
• Consult internal groups and support staff on procedural and budgetary matters during protocol review, including changes arising from protocol amendments.
• Secure other functions’ commitments to close gaps and address issues in a timely and effective manner.
• Serve as the chief liaison between sponsors and PPD internal departments throughout all study phases.
• Educate investigator sites by delivering protocol-specific laboratory procedures presentations and demonstrations at investigator meetings.
• Manage day-to-day clinical trial activities, resolve issues, and answer queries.
• Consult with IT and data management development groups on the design, validation, and implementation of software and functionality relevant to project management.
• Consult with business development and finance staff on initial project documentation, standard services and costs, and RFP feasibility assessments; advise on possible solutions and draft proposal responses.
• Guide and support the workflow of 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 procedural documents.
• Serve as backup for the Associate Director PM when needed.

Benefits

• Accessibility assistance or accommodations are available to job seekers with disabilities during the application process.

What This Job Offers

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