TMF Study Owner

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Job Details

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.

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

Minimum Skills Required :

Experienced in coaching and mentoring

Excellent presentation skills

Experienced in negotiation and conflict resolution

Working under pressure

Working arrangements : fully remote

LI-REMOTE

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

Affiliated Companies

Affiliated Companies : PhlexGlobal Poland