- 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
Associates - 4 Years with Degree in Life science
4+years with relevant skill - eTMF Periodic Review and/or CRA/Monitoring skills
- 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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