Tmf study owner Job at Cencora (Remote)

Job Description

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.

Job Responsibility

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 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

Requirements

Degree level education preferred, but equivalent work experience in a relevant field considered
5 years’ relevant industry experience in Clinical or TMF Operations oversight
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

What we offer

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

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Tmf study owner

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