Remote TMF Study Owner

Summary

Join our team at Cencora Pharmalex as a TMF Study Owner to provide pivotal support and subject matter expertise for clients' Trial Master Files (TMFs) to achieve an inspection-ready state. This fully remote role requires a strong understanding of Good Documentation Practices, document management, and quality oversight.

Requirements

• 5 years relevant industry experience in Clinical or TMF Operations oversight
• Excellent knowledge of: Good Documentation Practices (GDP)
• 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 pathways
• Proficient in: Verbal and written communication
• Independent in: Internal collaboration
• Interpersonal interactions
• Organization
• Prioritization
• Experienced in: Coaching & mentoring
• Presenting information
• Developing in: External collaboration and negotiation/conflict resolution
• Working under pressure and Information Analysis

Responsibilities

• Remain familiar with relevant SOPs and processes to support and signpost study team to relevant guidance
• 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
• 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
• 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