TMF Specialist — Hybrid, Remote 3 Days/Week

Piper Companies; Bethesda (MD); Hybrid; USD 50,000 - 85,000; Full time

Benefits offered by this job

Comprehensive benefits

401k with ADP

Paid holidays & PTO

Job summary

Piper Companies in Bethesda, MD is seeking a TMF Specialist to manage TMF set-up, quality management, reporting, and QA for a clinical research program. Hybrid role with three remote days per week, based in Bethesda.

You will ensure documentation complies with ICH/GCP, FDA, EMA TMF requirements, and SOPs, and maintain records for inspection readiness. Candidates should have 1+ year TMF experience and a BA/BS in a science or healthcare field.

Qualifications

• 1+ year TMF experience.
• Knowledge of FDA, ICH, EMA TMF requirements.
• TMF monitoring experience; TMF Plans/Indexes.
• Minimum B.A. or B.S. in science or healthcare field.

Responsibilities

• TMF set-up, quality management, reports and metrics, and TMF quality control/quality assurance.
• Ensure overall TMF document quality and completion, including filing and maintenance, cross-functional coordination, and TMF tracking and reporting to clients.
• Ensure documentation is consistent with eTMF specs, ICH/GCP, regulatory requirements, and SOPs.
• Maintain record information per TMF storage SOPs for inspection readiness.

Skills

TMF experience

FDA/ICH/EMA TMF requirements

TMF monitoring

Veeva Vault

Trial Interactive

Education

Bachelor's degree in science or healthcare field

Tools

Veeva Vault

Trial Interactive

Job description

Piper Companies in Bethesda, MD is seeking a TMF Specialist to manage TMF set-up, quality management, reporting, and QA for a clinical research program. Hybrid role with three remote days per week, based in Bethesda.

You will ensure documentation complies with ICH/GCP, FDA, EMA TMF requirements, and SOPs, and maintain records for inspection readiness. Candidates should have 1+ year TMF experience and a BA/BS in a science or healthcare field.