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Job Details

Career Details

Summary

Overview of Position:

The Trial Master File Specialist (TMF) 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.

Essential Duties & Responsibilities:

  • 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.
  • 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 timepoints, including any paper originals required.
  • Conduct TMF/eTMF content reviews and provide TMF/eTMF content reports to the project team on a regular basis.
  • Provide recommendations and/or implement process improvements.
  • 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, US Food and Drug Administration (FDA) and International Council for Harmonization (ICH) Good Clinical Practices (GCP) guidelines.
  • Participate in organizational process improvements as required.
  • Assists with maintaining up-to-date study status tracking and other tracking tools (as assigned).

Job Requirements:

Education: Associate degree or its International Equivalent in Computer Science, Life Science, Health Sciences or Information Management or Related Field

Experience:

  • A minimum of 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.
  • Prior experience in a non-governmental organization (NGO), government agency, or private organization

Technology to be used: Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office telephone, cell phone and printer/copier

Skills and Attributes:

  • Demonstrated ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.
  • Demonstrated ability to discuss strategic and sensitive issues.
  • Ability to work well with people and establish effective relationships across all levels of the organization.
  • Requires task orientation for projects but has a good understanding of how the task meets the deliverable objective.
  • 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.
  • 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 workload in a proactive manner.
  • Ability to work effectively under pressure of deadlines.
  • Demonstrated ability to make decisions involving conflicts of interest.
  • Expected travel time is less than 10% for this position.
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