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
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.