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Company Name: PPD Development, L.P.

Position Title: Project Manager - Labs

Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Monitor and manage all aspects of designated clinical trial protocols in Global Central Labs 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. Provide internal consulting on project management issues and identify opportunities for process and efficiency improvement. Act as chief liaison to the operational personnel of major sponsors and responsible for large study programs. Prepare and maintain process documents and act as a back-up for the (Associate) Director PM, when needed. 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 and ensure the project requirements are understood, agreed 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 the study specifications documents and follow the preparation according to budgets and contracts. Maintain at all times an updated study master file with version controls for specs, budgets and contracts. Ensure sponsors have authorized and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assure 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, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Obtain other functions’ commitment to close gaps and address issues timely and effectively. Serve as chief liaison between 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 work flow of Projects Managers and Set-up Administrators with special attention to training junior personnel. Perform as a mentor and trainer for newly assigned Project Managers and identify areas for development and efficiencies in performing tasks. Author, review, revise, and implement relevant procedural documents. Duties may be performed remotely.

Qualifications: Bachelor’s degree in Biology, Chemistry, Business and Information Systems, Software Engineering, or related field and two (2) years of experience as a Project Manager, Associate Project Manager, Data Manager, or related role. In the alternative, the employer will accept a Master’s degree in Biology, Chemistry, Business and Information Systems, Software Engineering, or related field, and six (6) months of experience as a Project Manager, Associate Project Manager, Data Manager, or related role. Must have six (6) months of experience with: Working with multi-level teams; Project management in laboratory environment; Specific computer and enterprise applications, including office productivity, ASSIST, ConneXion, MS Project Professional, OneNote, MS Word, and MS PowerPoint; Consulting with internal stakeholders over procedural and budgetary items during initial protocol review; Assuring compliance with FDA and Good Clinical Practice guidelines, personnel policies and procedures, IATA, and other regulations regarding the transport of biological specimens; and Preparing and maintaining process documents, and reviewing, interpreting, translating, and using program study protocols to create complete and accurate databases.

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