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Tmf study owner

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Cencora

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Location:
United States , Remote

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The TMF Study Owner provides pivotal support and subject matter expertise (SME) at a study level, proactively ensuring our clients’ Trial Master Files (TMFs) are achieving an inspection ready state. They are an integral part of the study team, becoming a single point of contact to help maintain TMF health, consistency, and compliance across clinical trials within the organization.

Job Responsibility:

  • Document Management & Quality: Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices
  • TMF Management: Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements
  • Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented
  • Monitor milestones and events to ensure TMF Completeness via eTMF functionality
  • Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team
  • Support study team through closeout and archive preparations
  • Ensure ongoing adherence to TMF SOPs and specifications
  • Create study-specific TMF Index (or equivalent)
  • TMF Health & Metrics: Perform and/or support Quality Review and perform spot-checks for quality oversight
  • Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining
  • Help facilitate, track, and support periodic Study Team TMF Reviews
  • Perform a deep dive of report outputs
  • identify and share trends and risk areas with Study Teams
  • Inspection Readiness: Manage remediation and reconciliation projects
  • Manage inspection preparation
  • Support audits and inspections
  • Support implementation of CAPAs at study level
  • Identify and escalate risk and trends impacting Inspection Readiness
  • Customer Relationships: Facilitate TMF-focussed communication and collaboration between Sponsor and CROs
  • Communicate to the Study Manager (or equivalent) on all aspects of the TMF
  • Build proactive relationships with study teams, providing continued SME support
  • Understand and utilise appropriate escalation pathways
  • Policies & Procedures: Provide feedback on processes relating to TMF Management
  • Training & Mentoring: Act as TMF SME, including related processes, to provide ongoing support to the Study Team
  • Provide feedback to support the development of internal and/or external TMF-related trainings
  • Conduct training for Study Team and/or colleagues, either 121 or in group setting
  • The employee agrees to take over additional reasonable tasks that align with their abilities, if required

Requirements:

  • Degree level education preferred, but equivalent work experience in a relevant field considered
  • 5 years’ relevant industry experience in Clinical or TMF Operations oversight
  • Excellent knowledge of Good Documentation Practices (GDP) and document recognition
  • Good knowledge of referencing/applying applicable resources
  • Working knowledge of: Clinical trial lifecycle, TMF Reference Model (or equivalent), eTMF systems, TMF Health & Metrics, including Quality Review process, Internal communication/escalation pathways
  • Familiar with: TMF lifecycle, Other clinical/document management systems, TMF stakeholders, End-to-end tasks, including TMF set-up process and Management Plans, TMF training, Inspection Readiness, External communication/escalation pathway
  • Proficient in verbal and written communication
What we offer:
  • We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day
  • In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
  • This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
  • To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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