Project Manager, Central Labs

Thermo Fisher Scientific seeks a Project Manager, Central Labs to oversee central laboratory activities across clinical trial programs. The role manages study execution and client satisfaction, coordinates cross-functional teams and sponsors, ensures regulatory and documentation compliance, and mentors project staff.

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 support workflow of Project Managers and Set-up Administrators with special attention to training junior personnel, perform as a mentor and trainer for (newly assigned) Project Managers, identify areas for development and efficiencies in performing tasks, author, review, revise and implement relevant procedural documents, and serve as a backup for the Associate Director PM when needed

Requirements:

• Must be legally authorized to work in the United States without sponsorship
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience
• Strong verbal, written and presentation skills
• Superior time management, planning, and organizational skills
• Competent with specific computers and enterprise applications, including office productivity
• 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 Global Central Lab environment
• Strong client relationship management skills
• Ability to work effectively with multi-level teams