TMF Study Owner

Responsibilities:

• Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance.
• Support the setup 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.
• 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.
• Manage remediation and reconciliation projects.
• Support implementation of CAPAs at study level.
• Identify and escalate risk and trends impacting Inspection Readiness.
• Facilitate TMF-focussed communication and collaboration between Sponsor and CROs.
• Act as TMF SME, including related processes, to provide ongoing support to Study Team.
• Provide feedback to support development of internal and/or external TMF-related trainings.
• Conduct training for Study Team and/or colleagues, either 121 or in group setting.

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Work experience:

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

Skills and Knowledge:

• Excellent knowledge of Good Documentation Practices 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, TMF set-up process and Management Plans, TMF training, Inspection Readiness
• Experienced in coaching and mentoring
• Excellent presentation skills
• Experienced in negotiation and conflict resolution
• Working under pressure

What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

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Equal Employment Opportunity

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