eTMF Specialist
Bangalore, India
4d ago

Job Overview :

  • Perform eTMF periodic Review of documents for Content & Completeness check
  • Perform eTMF Reconciliation tasks (Missing document, duplicates identification etc)
  • Follow with action owners for Open TMF Issues
  • Maintain the eTMF in state of Inspection Readiness
  • Ensure eTMF is always audit ready
  • Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends
  • Compliance to TMF Completeness, TMF Reviews & TMF Issue Resolutions
  • Commitment to continuous improvement of TMF delivery
  • Driving a culture of Inspection Readiness
  • Creating a seamless TMF delivery process
  • Education / Qualifications :

    Associates - 4 Years with Degree in Life science

    4+years with relevant skill - eTMF Periodic Review and / or CRA / Monitoring skills

    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 in 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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