Tmf Specialist

We are seeking a **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.

We are seeking a few dynamic **Consultant or Senior Consultant - Trial Master File (TMF) Specialists** to join our team of trusted experts. 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
- Hands-on TMF experience in the consulting, pharmaceutical, biotech, or CRO industry.
- Strong understanding of regulatory requirements and industry standards (ICH-GCP, DIA TMF Reference Model).
- Experience with eTMF systems (e.g., Veeva Vault, PhlexTMF, Wingspan, etc.).
- 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.
- Support clients with TMF health checks, inspections, readiness assessments, and gap analyses.
- Guide the implementation and optimization of eTMF systems and workflows.
- Train client teams on TMF best practices, metrics, and compliance requirements (e.g., ICH GCP E6(R2), DIA TMF Reference Model).
- Partner with cross-functional teams including Clinical Operations, Quality Assurance, and IT.
- Ensure inspection readiness and support mock audits and regulatory inspections.
- Contribute to the development of internal methodologies, accelerators, and knowledge sharing within Epista.
- Participate in business development activities, including proposal writing and client presentations.
- Mentor junior consultants (for Senior Consultant level).

**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 #beEpista

Epista is an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.

**Location**:
East Coast

Job type:
Full time

Application deadline:
As soon as possible

Employment date:
19. May 2025