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Trial Master File (TMF) Specialist

Job Attributes

Job Id:

18700

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is seeking a detail-oriented and motivated Trial Master File Specialist in Bethesda, MD to support an established research firm supporting commercial clients and government agencies with ongoing clinical research trials.

Responsibilities for the Trial Master File Specialist:

  • Provide support to the creation and management of assigned TMF’s to ensure each TMF is audit ready throughout the span of each clinical research trial
  • Receive, review and file trial documents submitted for the trial master file (TMF)
  • Coordinate resolution of trial document issues with related Research Sites, Data Management Teams, and Sponsors
  • Creation and maintenance of a document inventory
  • Review and process essential regulatory documentation for timely submission for the TMF
  • Generate metrics reports to assist with trial oversight and verify accuracy and completeness of the TMF
  • Review regulatory documents to ensure adherence to sponsor requirements, ICH, GCP, FDA Regulations and additional regulatory agencies
  • Must have excellent time management skills and be able to adhere to strict project timelines and expectations.

Requirements for the Trial Master File Specialist: 

  • 1+ years of experience managing TMF & EDMS systems
  • Experience with Clinical Research Trial Associate/Coordinator responsibilities
  • Working knowledge of database management programs, analytical tools, and
  • Bachelor or Master’s Degree in science-related field preferred

Compensation for the Trial Master File Specialist:

  • Salary up to $70,000 based on experience
  • Benefits: Health, Dental, & Vision insurance and 401K

 

Please send all qualified resumes to: idusci@pipercompanies.com

 

Keywords:

Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop, CTA, Clinical Trial Associate, CTMF, Clinical Trial Master File, EDMS, Electronic Data Management System, EDC, Electronic Data Capture

 

 

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Job Id:

18700

Job Category:

Clinical & Life Sciences

Job Location:

Bethesda, MD  20815

Security Clearance:

No Clearance

Business Unit:

Piper Companies