Labs Project Manager

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

Join Thermo Fisher Scientific Inc. as a Labs Project Manager supporting PPD’s Bioanalytical lab! This outstanding opportunity allows you to be part of a world-class team that successfully coordinates clinical trial projects. We strive for flawless execution, ensuring our clients' needs are met with proven solutions.

Group/Division Summary

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Responsibilities

• Provides oversight and coordination of study initiation.
• Reviews, interprets, translates, and programs study protocols into a complete and accurate database.
• Communicates with internal departments and external vendors, ensuring project requirements are understood, agreed upon, and followed at all times.
• Facilitates the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel).
• Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
• Prepares study specifications documents according to budgets and contracts.
• Maintains an updated study master file with version controls for specs, budgets, and contracts.
• Ensures sponsors have authorized and signed off on the most recent versions of all documents and that a contract exists prior to delivering any services.
• Assures compliance with FDA and Good Clinical Practice guidelines, PPD SOP’s, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.
• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments.
• Obtains other functions’ commitment to close gaps and address issues timely and effectively.
• Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.
• Educates Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meeting.
• Controls, manages, and follows day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.
• Actively consults with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities.
• Consults with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments.
• Advises on possible solutions if needed.
• Drafts responses for proposals.
• Guides and supports the workflow of Project Managers and Set-up Administrators.

Company Information

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.