Emmes Group is dedicated to advancing clinical research and improving patient outcomes through innovation. With over 47 years of experience, Emmes is a leader in clinical research, serving both public-private partnerships and commercial biopharma. They specialize in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. As an Associate TMF (Trial Master File) Specialist, you will play a key role in maintaining and organizing TMF documents while ensuring compliance with industry guidelines.
Primary Purpose
The Associate TMF Specialist is responsible for uploading, indexing, and maintaining TMF documents within an eTMF (electronic Trial Master File) system, ensuring compliance with SOPs, ICH/GCP guidelines, and TMF best practices.
Key Responsibilities
- Act as an SME (Subject Matter Expert) on eTMF features related to TMF operations, document filing, and processes.
- Follow the TMF Plan/Index, ensuring the collection of documents aligns with the plan.
- Ensure compliance with Good Clinical Practice (GCP) guidelines and the TMF Reference Model.
- Contribute to the development of SOPs, quality management reports, and quality control (QC)/quality assurance (QA) activities.
- Support the implementation of Veeva Vault eTMF system features with the Clinical Systems Manager.
- Participate in process streamlining and automation (e.g., VBA macros, Robotic Process Automation, AI/ML).
- Maintain the TMF lifecycle, including report generation and document tracking.
Qualifications
- Bachelor’s degree (preferably in a scientific discipline).
- 0 to 3 years of experience in Clinical Operations and TMF filing.
- Knowledge of eTMF applications and filing procedures (experience with Veeva is a plus).
- Strong organizational, planning, analytical, and problem-solving skills.
- Knowledge of GCP, TMF regulations, and the TMF Reference Model.
- Experience in NIH-sponsored clinical programs is a bonus.
- Ability to handle competing priorities and work in high-pressure environments.
- Strong communication skills and fluency in English.
Skills & Competencies
- High attention to detail and accuracy.
- Ability to build positive relationships with team members and management.
- Self-motivated and results-driven, with a strong initiative.
