Project Manager - Labs

2 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Monitors and manages all aspects of designated clinical trial protocols and is accountable for overall project performance and client’s satisfaction • 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. • 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 and ensures the project requirements are understood, agreed and followed at all times. • Facilitates the flow of technical and clinical laboratory information to all stakeholders. • 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 the study specifications documents and follows the preparation according to budgets and contracts. • Maintains at all times an updated study master file with version controls for specs, budgets and contracts. • Ensures sponsors have authorized and signed off the most recent versions of all docs 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 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 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 workflow of Projects Managers and Set-up Administrators. • Performs as a mentor and trainer for Project Managers, identifies areas for development and efficiencies in performing tasks. • Authors, reviews, revises and implements relevant procedural documents.

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. • 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 • Strong client relationship management skills • Ability to work effectively with multi-level teams

Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • range of employee benefits