Clinical eTMF Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and manage the electronic Trial Master File (eTMF) throughout the entire clinical trial lifecycle.

• Ensure the eTMF is complete, accurate, compliant, and ready for inspection.

• Monitor quality metrics of the eTMF and address any gaps or issues that arise.

• Conduct quality control checks and reconcile documents against the eTMF reference model.

• Collaborate with Clinical Operations, Quality Assurance, Regulatory Affairs, CROs, study sites, vendors, and cross-functional teams.

• Offer training and support on eTMF processes and best practices.

• Assist during regulatory inspections and sponsor audits.

• Identify and escalate compliance risks and issues related to documentation.

• Contribute to the development of SOPs, work instructions, and training materials.

• Aid in system enhancements, upgrades, and user acceptance testing (UAT).

• Perform other assigned responsibilities.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, or a related field (or equivalent experience).

• A minimum of 2–4 years of experience in clinical trial documentation, TMF, or eTMF management.

• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.

• Practical experience with eTMF systems (e.g., Florence, Veeva Vault, or similar).

• Preferred experience working with the TMF CDISC reference model and cross-functional clinical processes.

• Excellent attention to detail, organizational skills, and time management abilities.

• Outstanding written and oral communication and presentation skills.

• Strong interpersonal skills and ability to thrive in a team-oriented, collaborative environment.

• Capability to independently plan, organize, coordinate, manage, and execute assigned tasks and multiple projects.

• Willingness to travel as part of the role.

• Good understanding of applicable regulations.

• Highly self-motivated, well-organized, and confident.

• Possess a solution-oriented mindset with the ability to develop innovative solutions to challenges.

🏝️ Benefits

• Reasonable accommodations for applicants with disabilities.

• Willingness to travel is a component of the role.