Covance

  • Associate eTMF Manager

    Job Location(s) US-PA-King of Prussia
    Job Number
    2018-24275
    Job Category
    Clinical Trial Management
    Position Type
    Full-Time
  • Job Overview

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

     

    This position is responsible for supporting the Director of the Records Management function within processes Business Process & Solutions, implementing and maintaining Records Management systems and processes in CDCS to ensure compliance:

    • Consolidation of various records management vendors for cost effectiveness.
    • Implementing a streamlined, global process.
    • Ensuring compliance in how CDS stores, retrieves, refiles records.
    • Performing yearly testing of the process to ensure success during both audits and inspections.
    • Leading the decisions for accurate destruction of global records based on corporate retention guidelines.
    • Oversee and supervise the strategy execution for the records management components of the electronic trial master file system (eTMF) and the CDS records management needs.
    • Support the Director of Business Process & Solutions by performing delegated management tasks.
    • Create Standard Operating Procedures (SOPs) and Work Instructions for job functions within Records Managements, discovering and documenting process improvements.
    • Conduct initial contract negotiations with document archival vendors.
    • Plan for ongoing storage needs of paper documents.
    • Participate in Covance project teams and client meetings, as appropriate.
    • Ensure compliance of deliverables to applicable regulations, guidance requirements and client requests.
    • Coordinate and support the preparation and maintenance of project plans for Records Management projects and for subsequent adherence to the plans.
    • Present aspects of Records Management to auditors during client and/or regulatory inspections.
    • Any other duties as requested by management.

    Education/Qualifications

    Recommended:

    • 2 year college degree from an accredited institution or equivalent years of experience in records management function or life sciences.

    Preferred:

    • 4 year University/college degree form an accredited institution or equivalent years of experience.

    Experience

    Minimum Required:

    • Project management experience.
    • Experience of Record management, retention, requirements and systems utlized in records management for the pharmaceutical industry.

    Preferred:

    • 2 years' experience records management function in the pharmaceutical industry.

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