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Project Manager - Labs

Company: Thermo Fisher Scientific
Location: Richmond
Posted on: January 26, 2023

Job Description:

Title: Project Manager - Labs Division / Dept.: Analytical Services/ Bioanalytical Laboratory Location: Richmond, VA Office status: Office-based Note: Full time, Permanent, Benefits, 401K Welcome to PPD Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. As a Project Manager - Labs, you are committed to excellence and high-quality results. Your work as a project leader with a strong sense of urgency aligned to our customers, and you are committed to delivering results. Summarized purpose below:

  • Monitors and manage all aspects of post validation activities and accountable for overall post validation timeline from the time the validation lab work is complete through issue of final report.
  • Provides internal consulting on project management issues and identifies opportunities for process improvement and efficiency
  • Acts as chief liaison to the operational personnel for post validation activities, such as QC, report writing, and QA.
  • Responsible for ensuring the accuracy/quality of draft report prior to submitting to QA.
  • Prepares and maintains process documents and templates. Company Overview: PPD is part of Thermo Fisher Scientific. As the world's leader in serving science, our professionals develop critical solutions-and build rewarding careers. We offer services and products that help customers around the globe in laboratories and clinics, on production lines and out in the field. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer:
    • Continued career advancement opportunities
    • Individualized training approach
    • Work/ life balance Essential Functions:
      • Provides oversight and coordination of study initiation. Reviews, interprets, translates and programs plans into a complete and accurate database. Communicates with internal departments and external vendors and ensure the project requirements are understood, agreed and followed at all times. Facilitates the flow of technical and clinical laboratory information to all stakeholders (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 validation work.
      • Prepares the study specifications documents and follows the preparation according to 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 most recent versions of all docs and that a contract exists prior to deliver 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.
      • Obtains other functions' commitment to close gaps and address issues timely and effectively. Serves as administrative 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 validation work to resolve any issues and answer queries
      • Guides and supports workflow of Projects Managers and Set-up Administrators with special attention to training junior personnel. Performs as a mentor and trainer for (newly assigned) Project Managers, identifies areas for development and efficiencies in performing tasks. Authors, reviews, revises and implements relevant procedural documents. Serves as a back-up for the (Associate) Director PM, when needed. Education and Experience:
        • 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. Knowledge, Skills and 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: PPD 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: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)

Keywords: Thermo Fisher Scientific, Richmond , Project Manager - Labs, Executive , Richmond, Virginia

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