Covance

  • eTMF Specialist

    Job Location(s) US-PA-King of Prussia
    Job Number
    2018-24272
    Job Category
    Clinical Trial Support
    Position Type
    Full-Time
  • Job Overview

    This position will be office based in King of Prussia, PA.

     

    This position provides process, control, coordination, and approval of clinical trial documents. This position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).

     

    • Maintains an understanding of applicable regulatory requirement.
    • Manages the set up and maintenance of electronic Trial Master Files (eTMF), Trial, Country and Site artifacts) for clinical studies in accordance with TMF process, working with key personnel such as the Project Manager.
    • Leads the development, creates and maintains the eTMF Plan and TMF Index with Project Manager/Study Lead and/or sponsors.
    • Responsible for mapping the sponsors TMF Index, if applicable, to the Covance TMF Index and adds/modifies all approved TMF artifacts in the Covance TMF Index, accordance to Covance SOP's, and/or sponsor SOP's.
    • Maintains the TMF in a state of audit readiness for quality and compliance by:
      • Visual quality checks of e-documents prior to release to confirm image clarity and readability.
      • Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate;
      • Initiating the What's Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and study milestones.
    • Comply with metrics established for performance TMF reviews.
    • Process and track final essential artifiacts required throughout all phases of the study in accordance with Covance SOPs, sponsor SOPs, GCP and ICH guidelines.
    • Manages the identification of operational and logistical issues and resolutions related to the TMF.
    • Responsible for gathering data requested by study team to support status reports to clients.
    • Prepares the TMF for QA or Sponsor audits, leads the resolution with identifying and implementing corrective actions to findings in audit reports.
    • Participates in client audits and regulatory inspections by providing guided access to the eTMF study area.
    • Review and respond to the TMF content quality issues and identifies trends per study and across programs; alerts management of trends.
    • Proactively prepares the TMF study artifacts for export and transfer to the Sponsor at interim points and/or at the end of the study, working with the Project Manager, Clinical Business Administrator, and Records Management Associate/Assistant.
    • Acts as backup to local Records Management Associate/Assistant as necessary.
    • Collaborates with all members of BP&S.
    • Ensures overall client satisfaction for all studies.
    • Participates in business improvement initiative to drive quality, productivity and continuous improvement of business processes.
    • Maintains an understanding of applicable regulatory requirements.
    • Attend internal or external study team meetings as required.
    • Perform other study related duties as assigned.

    Education/Qualifications

    • Associate's (2-year) Degree with a Life Sciences/Business focus.

    Preferred:

    • Bachelor's (4-year) Degree with a Life Sciences/Business focus.
    • Equivalent experience within clinical research environment of 5+ years may be substituted for education requirements.

    Experience

    • Minimum 4 years' experience working in a clinical research environment.
    • Understanding of GCP and ICH guidelines.
    • Knowledge of Regulatory/Clinical document requirements.
    • Extensive experience working clinical electronic systems.
    • Extensive knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
    • Excellent interpersonal skills.

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