PharmaLex is hiring a
TMF Study Owner

Summary

The job involves a TMF Study Owner role in the Professional Services team at Cencora Pharmalex. The position is fully remote and requires 5 years of relevant industry experience in Clinical or TMF Operations oversight. Key activities include document management, TMF management, TMF health & metrics, inspection readiness, customer relationships, policies & procedures, and training & mentoring.

Requirements

• Technical Expertise - 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 pathways

Responsibilities

• Document Management & Quality
• TMF Management
• TMF Health & Metrics
• Inspection Readiness
• Customer Relationships
• Policies & Procedures
• Training & Mentoring