SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract eTMF Specialist to join our client's pharmaceutical clinical research team. The eTMF Specialist is responsible for managing and maintaining the electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements and company standards.

*12 month plus long term contract; REMOTE

MUST HAVES:

• 5 years of pharmaceutical industry or drug development experience required
• At least 3 years TMF experience required, including experience in study start-up, maintenance and closeout, and performing quality and completeness reviews
• Veeva Vault exp and be very well versed with this software
• Manage the process of EDLs, within Veeva Vault
• Quality Reviews through Veeva Vault
• Certification in clinical research or eTMF management- preferred

JOB RESPONSIBILITIES:

• eTMF Oversight: Manage the initiation, ongoing maintenance, and final closure of electronic Trial Master File (eTMF) systems across clinical studies.
• Regulatory Compliance: Ensure all eTMF documentation aligns with applicable regulatory standards, including ICH-GCP, FDA, EMA, and other governing bodies.
• Document Quality Assurance: Conduct routine audits and quality reviews of eTMF content to verify accuracy, completeness, and compliance. Supervise CROs in their TMF responsibilities and confirm the final TMF is inspection-ready and suitable for regulatory submissions.
• Training & Support: Deliver guidance and training to both internal teams and external partners on eTMF procedures, tools, and best practices.
• Cross-Functional Coordination: Partner with Clinical Operations, Regulatory Affairs, Global Medicines Development, and other stakeholders to ensure eTMF processes are integrated and compliant across functions.
• Document Management: Lead the creation of study-specific eTMF plans. Oversee the proper upload, classification, and organization of trial documents. Maintain and update Essential Document Lists (EDLs) throughout the study lifecycle.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.