TMF Study Owner

Cencora; United Kingdom; On-site; GBP 45,000 - 65,000; Full time

Job summary

Cencora is seeking a TMF Study Owner to manage the study-specific TMF structure, ensuring compliance and facilitating communication between stakeholders. The role requires expertise in TMF operations and clinical trial lifecycle, along with strong mentoring and presentation skills. Join us to make a difference in healthcare!

Benefits

Benefit offerings aligned to local market practice

Qualifications

• 5 years relevant industry experience in Clinical or TMF Operations oversight.
• Excellent knowledge of Good Documentation Practices and document recognition.
• Working knowledge of clinical trial lifecycle and TMF Reference Model.

Responsibilities

• Monitor study events and ensure updates to the study-specific TMF structure.
• Write/initiate creation of the study-specific TMF Management Plan.
• Support study team through closeout and archive preparations.

Skills

Excellent presentation skills

Experienced in coaching and mentoring

Experienced in negotiation

Conflict resolution

Working under pressure

Job description

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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!

This role is in support of Cencora's global pharma consulting services marketed through our PharmaLex business.

AS TMF Study Owner you will be responsible for supporting the setup of the study-specific TMF structure, liaising with the Study Team to establish requirements, monitoring milestones and events to ensure TMF Completeness via eTMF functionality.

Responsibilities:

Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance.

Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented.

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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Requirements:

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

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

Skills:

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.

Full time