TMF Study Owner

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.

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.

Education:

• Degree level education preferred, but equivalent work experience in a relevant field considered

Work Experience:

• 5 years' relevant industry experience in Clinical or TMF Operations oversight.

Skills and Knowledge:

• 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

#LI-AT2

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. For details, visit https://www.virtualfairhub.com/cencora

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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