Project Manager, Central Labs

Thermo Fisher Scientific•Highland Heights, KY

2d•Remote

About The Position

The Project Manager, Central Labs leads and coordinates central laboratory activities across clinical trial programs. The role monitors and manages designated clinical trial protocols in Global Central Labs and is accountable for project performance and client satisfaction throughout the trial lifecycle. The Project Manager provides internal consulting on project management, identifies process and efficiency improvements, serves as chief liaison to operational personnel at major sponsors, and is responsible for large study programs. The position also maintains process documents and mentors other Project Managers. This is a fully remote role supporting Global Central Laboratories. Applicants may be located anywhere in the United States and must be legally authorized to work in the United States without sponsorship. Candidates must pass a comprehensive background check, including drug screening. The role follows a standard Monday–Friday schedule and may require travel.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 2 or more years of previous experience providing the knowledge, skills, and abilities to perform the job, 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.
Ability to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
Ability to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

Oversee and coordinate study initiation, reviewing, interpreting, translating, and programming 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 among investigational sites, sponsors, and non-technical personnel.
Consult laboratory management and technical staff for scientific input to help clients manage clinical trials.
Prepare study specification documents according to budgets and contracts, and maintain an updated study master file with version controls for specifications, budgets, and contracts.
Ensure sponsors authorize and sign off on current 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 protocol review on procedural and budgetary matters and changes arising from protocol amendments.
Obtain commitments from other functions to close gaps and address issues promptly and effectively.
Serve as the chief liaison between sponsors and internal PPD departments throughout all study phases.
Educate investigator sites by presenting and demonstrating protocol-specific laboratory procedures 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, costs, and RFP feasibility assessments; advise on solutions and draft proposal responses.
Guide and support Project Managers and Set-up Administrators, with particular attention to training junior staff.
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.