FHI 360

TMF Specialist

FHI 360

Job Description

The TMF Specialist II is responsible to deliver controlled and quality trial master file documents for the purposes of regulatory and health authority inspections; and to ensure compliance as delegated by trial sponsors and under applicable institutional policy.


  • Responsible for paper Trial Master File (TMF) set-up, maintenance, update,  archival and destruction (if applicable) in accordance with FHI Clinical processes, Sponsor requirements, and applicable regulations.

  • Responsible for comprehensive review and approval of TMF/eTMF  Management plans.

  • Responsible for assessing training needs of staff regarding TMF/eTMF document delivery and implementing training (individual and/or departmental).

  • Responsible for maintaining systems and tools for evaluating, tracking, and transmitting trial master file documents.

  • Responsible for authoring, revising, and or coordinating review and approval of departmental  Work Instructions.

  • Ensure adequate set-up of master files including proper and timely filing of all relevant study documents.  Maintain documents master files according to regulatory and company defined standards.

  • Conduct detailed and appropriate quality checks on TMF/eTMF documents at defined time points, including any paper originals required.

  • Conduct TMF/eTMF content reviews, provide  TMF/eTMF content reports on a regular basis.

  • Scan (or coordinate scanning) of documents. Label scanned documents and import into internal systems to ensure availability.

  • Assist  in the management of the Document Control Room including maintenance of systems.  Provide  recommendations and/or implement  process improvements.

  • Develop  and maintain  Document Management control room logs, manuals, and work instructions to ensure they are accurate, up to date and available to appropriate personnel.

  • Ensure that FHI Clinical privacy and Security standards are met and adhered to.  Ensure that documents are maintained in accordance with FHI Clinical retention practices.

  • Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Policy & Procedures, FDA and ICH GCP guidelines.

  • Participate in organizational process improvements as required.

  • Maintains a computer database of all filed documentation to ensure fast retrieval of documents.

  • Assists with maintaining up-to-date study status tracking and other tracking tools (as assigned).

Applied Knowledge & Skills: 

  • Ability to work well with people and establish effective relationships across  all levels of the organization.

  • Strong computer skills (MS Office), SharePoint, and Acrobat.

  • Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.

  • Ability to coordinate review and finalization of documents with multiple stakeholders.

  • Aptitude to learn additional software programs and databases quickly.

  • Ability to handle multiple tasks simultaneously; manage and prioritize work load in a proactive manner.

  • Ability to work effectively under pressure of deadlines.

  • Demonstrated ability to make decisions involving conflicts of interest.

  • Excellent attention to detail.

  • Knowledge of clinical trial Design, execution, and operations.

  • Must be able to read, write and speak fluent English.

Problem Solving & Impact:

  • Demonstrated ability to discuss strategic and sensitive issues.

  • Requires task orientation for projects.

  • Able to identify improvements in the process to meet the objective and/or recommend alternative tasks that meet objective.

  • Achieves quality and timeliness of objectives.

  • Exercises judgment within defined policies and procedures to obtain solutions and perform duties.

  • Decisions made generally affect own job or specific functional area.

  • Makes decisions that may affect cross-functional processes and other organizational areas.

Supervision Given/Received:

  • Has no supervisory responsibility.

  • Receives instructions on new assignments.

  • Typically reports to a Manager.

  • Provides instructions on new tasks and assignments to staff person.


  • Associate’s Degree or its International Equivalent in Computer Science, Life Science, Health Sciences or Information Management or Related Field or the equivalent of relevant experience.


  • 1 - 3 Years of documentation management and experience with FDA, ICH, and GCP guidelines.

  • Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practices pertaining to clinical trial document management and archiving.

  • Prior experience working in a cross-matrix environment.

  • Experience with clinical study electronic databases.

Technology to be Used:

  • Personal Computer, e-mail, telephone, printer, calculator, copier, cell phones, and other hand held devices.

  • Strong computer skills (MS Office), Sharepoint, Acrobat and ability to work in FHI Clinical databases.

  • Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.

  • Ability to coordinate review and finalization of documents with multiple stakeholders.

Typical Physical Demands:

  • Typical office environment.

  • Ability to sit and stand for extended periods of time. * Ability to lift 5-50 lbs.

Travel Requirements:

  • Less than 10%.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable Law. FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
Apply Now