Senior eTMF Specialist

We are seeking a dedicated Senior eTMF Specialist who supports sponsor-side eTMF operations and CRO oversight activities for assigned clinical studies.

Requirements

• BSc required in a biomedical, life science, or related field of study
• Minimum of 4 years’ industry experience in supporting the operations of clinical studies, including duties related to TMF Operations oversight.
• Proficiency with TMF, GCP and eTMF systems.
• Expertise in Veeva Vault system (e.g., eTMF).
• Must have TMF experience working at a sponsor company and not only CRO environment.
• Understanding of DIA TMF reference model and cross-functional clinical processes.
• Demonstrated experience or knowledge with the clinical research process, including the collection of documents at study start-up, during study conduct and close-out.
• Demonstrated understanding of TMF related ICH/GCP guidelines.
• Familiarity with the management of global clinical trials, clinical trial documents and the TMF document management process.
• Experience with the Veeva electronic trial master file system(s) including uploading, reviewing, quality checks (QC), and approval of study required documents.

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package