Advanced Group

  • Document Management Associate

    Job Locations US-Remote
    Req No.
    2018-9095
    Category
    Operations
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    The Document Management Associate (DMA) is responsible for the set-up, maintenance, review, and archival of the trial master file (TMF) including quality assessments thereof, and tracking and reporting of key performance indicators. The DMA is a member of one/multiple project team(s) and is responsible for ensuring an audit-ready TMF.  

    Responsibilities

    1. Essential Functions
      • Responsible for the set-up (either paper or electronic), coordination, and preparation of the trial master file (TMF) repository, for management of existing and new TMF records as per the TMF Plan.
      • Process TMF records (paper or electronic) in accordance with Advanced Clinical, client, and industry-standard procedures, including certified copy attestation, metadata indexing, and data mapping from legacy structures.
      • Responsible to conduct or assign TMF quality control (QC) reviews for inspection readiness in accordance with Advanced Clinical, client, and industry-standard conventions and regulated record acceptability criteria, e.g., ALCOA.
      • Generate and maintain metrics tracking tools and communicate TMF status and QC results to the Project Manager and/or relevant parties through resolution.
      • As required for paper TMFs, prepare and maintain the document reconciliation worksheet (DRW) and collaborates with CRAs in an iterative process to maintain alignment between the TMF and Investigator Site File (ISF).
      • Responsible for transfer and/or archival preparation of the TMF.
      • Perform or assign Vault eTMF administration activities including study set up and user account management.
      • Possess a clear understanding of, and train internal and external (e.g., Sponsors, investigator sites, and third party vendors) staff on, Veeva Vault eTMF system and related procedures.
      • Demonstrate technical knowledge of document management with general understanding of applicable regulatory requirements, including electronic technology industry standards, e.g., 21CFR11.
      • Produce documents for and participate in, as directed, internal or external audits

    Qualifications

    3.1 Education - An Associate’s or Bachelor’s Degree is preferred but not required.

     

    3.2 Training - On the job or professional training in critical document review required. Demonstrated understanding of the TMF Reference Model filing structure, and clinical electronic document management systems.

     

    3.3 Certification – None required. Veeva Vault Administrator Certification preferred.

     

    3.4 Experience - Three (3) years industry experience with at least two (2) years of experience working directly with clinical trial documentation. Experience with Veeva Vault, or other EDMS systems strongly preferred. The ideal candidate has excellent organizational and time management skills and attention to detail, with an ability to maintain productivity and quality in a time-sensitive regulated environment. Must possess strong computer acumen & proficiency with Microsoft Office Suite and familiarity with clinical trial applications. Must possess knowledge of and demonstrate ability to apply pertinent applicable regulations and guidelines including Good Documentation Practice and Good Clinical Practice.

     

    Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.

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