TMF Study Owner

Cencora

10d

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details 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.

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

Responsibilities

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 Metrics 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.