Clinical Records, TMF Specialist

Are you ready to #BeEpista?

At Epista, you will grow a career in a setting that cherishes curiosity, integrity, and development. Epista Life Science is dedicated to defining and delivering process, technology and compliance excellence. Since our founding, we've expanded into multiple countries with big ambitions for the future. Our team is our superpower – and we want you to be a part of it. If you're interested in #BeingEpista, get in touch, we want to hear from you.

We are seeking a Clinical Records, TMF Specialist to join our growing US team. In this role, you will work directly with leading BioPharma and Life Science companies to improve business processes across the R&D lifecycle. You will serve as a critical link between business needs and technical solutions, ensuring our clients achieve measurable results and long-term value.

In this role, you'll partner with Life Science clients to provide hands-on expertise and strategic guidance in managing and optimizing TMF systems and processes. You'll have the opportunity to drive excellence in clinical documentation compliance while leveraging digital transformation and industry best practices.

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, or a related field or posses relevant experience in lieu of degree
• 3+ years of experience in Clinical Records Management or TMF Operations.
• Knowledge of eTMF systems (Veeva Vault preferred) and TMF Reference Model.
• Understanding of ICH-GCP and inspection requirements.
• Strong communication and collaboration skills with internal teams and external partners.
• Experience supporting vendor oversight and CRO coordination for document management activities.
• Analytical mindset and ability to translate complex compliance requirements into pragmatic solutions.
• Excellent communication, presentation, and stakeholder management skills.

• Ability to work in a collaborative, client-facing consulting environment.

• Monitor and report on TMF metrics and document completeness across studies and vendors.

• Prepare summary reports and dashboards for leadership and audit support.
• Coordinate with internal clinical operations, QA, and records management teams to address findings or process improvements.
• Contribute to development and refinement of TMF governance and oversight processes.
• Ensure ongoing inspection readiness by maintaining TMF quality and compliance to standards.
• Support TMF health checks and periodic completeness reviews.
• Partner with CROs and vendor partners to resolve TMF quality or timeliness issues.

What We Offer

• A values-driven, collaborative team environment
• Opportunities for career growth and continuous learning
• The chance to work with top-tier clients and industry leaders
• Competitive compensation and benefits
• Flexibility to work remotely within the US

Epista is a team of pioneers. We unlock each consultant's potential to continuously improve. We pioneer new ways to stay in control of patient safety and product quality and question the status quo in everything we do.

Our unique team spirit makes a positive impact – on our clients and the Life Science industry. Here, you're never alone. We all work together for everyone's success. And each individual is strengthened by the knowledge of the group.

We're proud to be Epista, for good reason. Are you ready to #BeEpista?

Epista is an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need. This position requires the selected candidate to be legally authorized to work in the United States without the need for current or future visa sponsorship

Please note that applications from third-party recruiters or recruitment agencies will not be accepted at this time. Applications must be submitted directly by individual candidates interested in this position.

Location:

, West Coast, East Coast

Job type:

Full time

Application deadline:

As soon as possible

Employment date:

As soon as possible