Senior TMF Study Owner

Remote

Temporary

Mid Level

Senior TMF Study Owner (Professional Services) 6 Months for UNITED STATES region only

Cencora Pharmalex is looking for a well experienced TMF Lead to step in and provide support in a well established team who require a short term engagement (6 months), we are looking for someone who can hit the ground running and is a self starter able to fit well into a established team.

Purpose
The Senior 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. For a Senior TMF Study Owner, the focus is on supporting more complex studies, with the additional responsibility of coaching and mentoring other TMF Study Owners.

Key Activities
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, and advise on best practices.

TMF Management

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.
Create study-specific TMF Index (or equivalent).

TMF Health & Metrics

Perform and/or support QR and perform spot-checks for quality oversight.
Provide TMF Health status updates and review metric reports outputs with the study team on a recurring basis, including verbal and/or written summaries.
Help facilitate, track, and support periodic Study Team TMF Reviews.
Maintain TMF Health oversight over study lifecycle.
Review metric report outputs with Study Teams on a recurring basis.
Perform a deep-dive of report outputs; identify and share trends and risk areas with Study Teams.
Identify strategies and provide guidance on how to improve and maintain TMF Health and metrics.

Inspection Readiness

Manage remediation projects.
Manage retrospective 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.
Develop proactive risk identification and escalation practices.

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 support utilisation of appropriate escalation pathways.

Team Management, Training & Mentoring

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.
Mentor staff in preceding roles and be point of contact for issue escalation.

For Line Managers only:

Support SO development, identifying training and personal development opportunities.
Support workload resourcing.
Assume line management responsibilities.
Support team recruitment.

Policies & Procedures

Review and/or comment on Policies and Procedures relating to TMF Management.

Cencora, a Pharmalex/Phlexglobal Company, is an equal opportunity employer and welcomes everyone to join our growing team. We make sure that we comply equality, diversity and inclusion in all our offices and prohibit against any discrimination on basis of race, religion, colour, sex, age, martial status or disability status etc. 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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Senior TMF Study Owner

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