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Tier-1 employer, metro location, mid-level experience increases competition; niche TMF skills somewhat limit applicant pool.
Highly domain-specific TMF and regulatory expertise limits transferability across industries.
Explicit 5–7 years, mandatory eTMF/Veeva and regulatory expertise enforce strict shortlisting.
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Supervise and allocate resources within a team of eTMF Specialists for document upload and management in electronic Trial Master File supporting BMS clinical trials.
Ensure quality standards for document uploading and review meet ICH GCP guidelines and ALCOA Plus principles, maintaining inspection-readiness and compliance.
Lead hiring, performance management, training, and development of the team while collaborating cross-functionally to maintain regulatory compliance and identify process improvements.
5–7 years of experience in health sciences or a related regulated industry.
Proven supervisory experience specifically for eTMF activities including training and coaching team members.
Strong knowledge of TMF principles, eTMF systems (preferably Veeva Vault eTMF), and clinical document management.
Proficiency with Microsoft Excel, PowerPoint, SharePoint, and PowerBI for reporting and analysis.
Experienced in managing and directing eTMF operations with a focus on compliance and quality in clinical trial documentation.
Technically adept at using and maintaining reports/dashboards within eTMF systems and capable of delivering TMF-related training across teams.
Strong understanding of global and local regulatory requirements impacting TMF and clinical trial documentation management.