TMF Manager

5 days ago

Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices.


Responsibilities -

  • Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs).
  • Performs set up activities, document filing and oversight of internal e/TMF applications.
  • Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications.
  • Functional lead for specified e/TMF platform with vendor(s).
  • Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines.
  • Provide training to eTMF users and external parties (CROs).
  • Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions.
  • Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate.
  • Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control.
  • Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems.
  • Work in collaboration with all applicable functional areas.
  • Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate.


Qualifications -

  • Bachelor’s degree or equivalent combination of education/experience in science or health- related field.
  • Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization.
  • Thorough knowledge of all sections of the DIA Reference Model (current version).
  • Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements.
  • Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles.


Required Skills -

  • Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.
  • Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals.

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