Labs Project Manager

Work Schedule

Environmental Conditions

Job Description

Join us as a Project Manager - Labs – make an impact at the forefront of innovation. The Project Manager - Labs monitors and manages all aspects of designated clinical trial protocols in Global Central Labs and BioAnalytical laboratories 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. Provides internal consulting on project management issues and 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. Prepares and maintains process documents and acts as a back-up for the (Associate) Director PM, when needed. Mentors Project Managers. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

DESCRIPTION

What You'll Do:

• 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.
• Manage BioAnalytical (BioA) project activities by collaborating closely with laboratory Principal Investigators (PIs) to advance study objectives. Effectively communicate using BioA-specific terminology and demonstrate strong English proficiency in technical and scientific documentation to ensure accurate interpretation and execution of bioanalytical protocols and requirements.
• 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

Education and Experience Requirements:

• 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.
• Previous experience in Global Central Labs (GCL) and/or BioAnalytical (BioA) project management preferred

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

• 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

Working Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Why join us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.