Clinical Trial Associate

  • location: King of Prussia, PA
  • type: Contract
  • salary: $40 - $44 per hour

job description

Clinical Trial Associate

Job Title: eTMF Specialist - Veeva Vault - System Administration

Position Description

  • The eTMF Specialist will provide systems support for the electronic Trial Master File (TMF) to the Study File Management (SFM) group and to clinical teams.
  • This role will be responsible for working with study teams, both internal and external, to support eTMF administration, account management, and study set up and maintenance.
  • General activities of the position will include, but are not limited to: user account management and training, the set up and maintenance of studies within the eTMF system, including study archival, system support and troubleshooting, including managing change and deletion requests in the eTMF system, assisting with inspections and audits, and development and generation of metrics.
  • The eTMF Specialist will also participate in the development and support of process improvement initiatives within the eTMF system and in preparing training materials and resources to support eTMF system and processes.
Position Responsibilities

  • Provide systems support for the eTMF system, Veeva's Vault to users, including:

    - Systems training and account administration

    - Study setup, maintenance, and archival

    - Change and deletion requests

    - System support and troubleshooting, including management of change and deletion requests

    - Audit/inspection support
  • Assist with implementation of the framework for a standard, global structure and maintenance of the electronic Trial Master File (eTMF)

    - Use audit and inspection findings, ICH-GCP, local and regulatory guidelines, and industry best practices to develop and improve upon global eTMF processes

    - Continuous evaluation and support of of electronic document repositories and compatability with Vault eTMF

    - Identify and develop templates, tools and processes for eTMF based on training needs and process gaps

    - Assist with developing and updating eTMF processes such as quality control processes, certified copy processes and systems integrations efforts (e.g., CTMS, Central Data Warehouse, Investigator Portals, etc.).
  • Assist with the development and reporting of TMF metrics to management and stakeholders (e.g., oversight, compliance, inspection readiness and completeness of TMFs).
  • Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all CSL geographical regions. Foster communication with management throughout the organization to promote increased cooperation and accountability.
  • Ad hoc support for any activities within Study and Business Operations in support of meeting objectives or timelines. This may include tasks such as filing documents in the TMF, archiving of paper or electronic media, support or maintanence of TMF room.
Position Requirements

  • Bachelor's Degree
  • A minimum of 4+ years relevant clinical research experience within the pharmaceutical industry
  • Experience with document management and/or electronic Trial Master File systems (e.g., Documentum, Wingspan, Trial Interactive, Veeva Vault, etc.)
  • Experience in the set-up and maintenance of Trial Master Files (paper/electronic) and sound knowledge of ICH-GCP guidelines and regulatory requirements as they apply to the Trial Master File
  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing timelines
  • Involvement working cross-functionally, with multicultural and international study teams
  • Comfortability and patience with training and troubleshooting technical issues
  • Vendor management and vendor oversight skills are desirable
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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