Tmf Study Owner
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PharmaLex
Job highlights
Summary
Join Cencora Pharmalex's Professional Services team as a fully remote TMF Study Owner in the Boston/Cambridge area. You will provide subject matter expertise and pivotal support, ensuring clients' Trial Master Files (TMFs) are inspection-ready. This role involves managing TMF health, consistency, and compliance across clinical trials, acting as a single point of contact for the study team. Responsibilities include document management, TMF management, health and metrics, inspection readiness, customer relationship management, policy and procedure feedback, and training and mentoring. The position requires extensive experience in clinical or TMF operations and a strong understanding of relevant regulations and technologies. Occasional travel may be required.
Requirements
- 5 years relevant industry experience in Clinical or TMF Operations oversight
- Excellent knowledge of: Good Documentation Practices (GDP)
- Excellent knowledge of: Document recognition
- Good knowledge of: Referencing/Applying applicable resources
- Working knowledge of: Clinical trial lifecycle
- Working knowledge of: TMF Reference Model (or equivalent)
- Working knowledge of: eTMF systems
- Working knowledge of: TMF Health & Metrics, including Quality Review process
- Working knowledge of: Internal communication/escalation pathways
- Familiar with: TMF lifecycle
- Familiar with: Other clinical/document management systems
- Familiar with: TMF stakeholders
- Familiar with: End to end tasks, including TMF set-up process and Management Plans
- Familiar with: TMF training
- Familiar with: Inspection Readiness
- Familiar with: External communication/escalation pathways
- Proficient in: Verbal and written communication
- Independent in: Internal collaboration
- Independent in: Interpersonal interactions
- Independent in: Organization
- Independent in: Prioritization
- Experienced in: Coaching & mentoring
- Experienced in: Presenting information
Responsibilities
- Remain familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices
- 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)
- 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
- Provide guidance on how to improve and maintain TMF Health
- 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
- Provide guidance on how to improve and maintain metrics
- Manage remediation and 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
- 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
- Provide feedback on processes relating to TMF Management
- 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
Preferred Qualifications
- Developing in: External collaboration and negotiation/conflict resolution
- Developing in: Working under pressure
- Developing in: Information Analysis
Benefits
- Fully remote role
- Working hours expected to match the requirements of the customer’s business day
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