Overview
TMF Specialist Jobs in Bethesda, USA at Zachary Piper Solutions
Zachary Piper Solutions is seeking a TMF Specialist to support our client in Bethesda, MD
. The TMF Specialist will manage the setup, maintenance, quality, and inspection readiness of Trial Master Files (TMF) across one or more clinical studies, ensuring compliance with ICH/GCP, FDA, and EMA requirements while serving as a subject matter expert to project teams.
Responsibilities of the TMF Specialist include:
- Manage TMF setup, maintenance, quality control, and quality assurance activities across clinical trials
- Ensure TMF completeness, accuracy, and timeliness in alignment with eTMF specifications, ICH/GCP, and regulatory requirements
- Perform QC review and approval of TMF documents to maintain inspection readiness
- Coordinate cross-functional document collection, filing, tracking, and reporting within the eTMF
- Serve as TMF subject matter expert, advising project teams on TMF standards, issues, and best practices
- Support audit and inspection readiness activities, including record retrieval and study closeout
- Assist with TMF SOPs, training materials, and mentoring of junior staff as applicable
Qualifications for the TMF Specialist include:
- Bachelor’s degree in science, healthcare, or a related field
- Experience working with eTMF systems (Veeva Vault or Trial Interactive preferred)
- Strong knowledge of ICH-GCP guidelines and regulatory requirements for clinical documentation
- Experience reviewing TMFs for completeness, timeliness, and accuracy
- Excellent organizational skills with strong attention to detail
- Effective written and verbal communication skills with internal and external stakeholders
- Proficiency with Microsoft Office applications
Compensation for the TMF Specialist includes:
- Salary Range: $20/hour – $27/hour depending on years of experience
- Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset
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Title: TMF Specialist
Company: Zachary Piper Solutions
Location: Bethesda, USA
Category:
