Prepare TMF plans, QC and indexing per GCP/ICH E6 guidelines.
Monitor document submissions to prevent backlog; escalate to eTMF mgmt.
Distribute TMF metrics and follow up on clarifications; resolve timely.
Manage close-out activities for studies, including final submission and transfers.
Ensure compliance with 21 CFR Parts 312/314 and EMA directives and SOPs.
Collaborate with internal and external stakeholders with professional communication.

🎯 Requirements

4-year college degree or equivalent, ideally in business/science/healthcare.
Minimum 5 years of clinical trial experience; at least 3 years with TMF/eTMF.
Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint); English proficient.
Knowledge of ICH-GCP and related regulatory guidance.

🎁 Benefits

Equal Opportunity Employer (EOE).
Reasonable accommodations available upon request.

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