Tmf Manager

Summary

Join Cytokinetics as a TMF Manager Consultant and oversee the day-to-day operations of study-specific TMF management. You will be responsible for reviewing and approving TMF plans, participating in quality control, facilitating record submissions and archival, and ensuring compliance with regulatory requirements. This pivotal role involves collaborating with the Clinical Operations team and external CROs. You will act as a subject matter expert on TMF processes, identify and mitigate risks, and support various TMF-related activities throughout the study lifecycle. The position requires a Bachelor's degree, extensive TMF management experience, and knowledge of relevant regulations and guidelines. Cytokinetics values its employees and offers a collaborative and rewarding work environment.

Requirements

• Bachelor’s Degree preferred
• 5+ years’ experience managing or supporting TMF activities for clinical research/ biotech/ CRO company – preferably within a role seated in a records/ document/TMF Management department
• 1+ years of experience serving as eTMF Administrator – preferably Veeva Vault TMF experience
• Experience in managing TMF documents during regulatory inspections
• Working knowledge of CDSIC Trial Master File Reference Model and ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6 (R2) guidelines
• Working knowledge of applicable FDA, Canadian, EU, and ICH guidelines related to clinical trial and eTMF management
• Ability to multi-task and manage several projects in parallel while paying attention to detail
• Strong critical thinking skills and ability to contribute creative yet practical solutions to problems
• Proactive, self-motivated, excels at cross-functional relationship building and can work independently with minimal supervision

Responsibilities

• Review and approve all applicable TMF Plans (e.g., internal/ external TMF Plan Migration plans, TMF Index)
• Participate in the Quality Control of documents (paper and electronic) submitted to the TMF
• Facilitate the review and submission of TMF records, as well as complete the archival process
• Support the coordination of the transfer of study-specific trial master files from the CRO
• Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
• Ensure study team compliance to Cytokinetics policies and regulatory requirements related to TMF to ensure TMF Inspection readiness in real time
• Act as TMF business process SME, proving operational experience on TMF-related processes to internal and external TMF stakeholders
• Identity and mitigate TMF-related risk and quality issues. Also, identify any corrective actions which must be addressed and assigned, collect missing and expired documents, and resolves TMF discrepancies
• Support the management of TMF-related activities (e.g., TMF Reviews, Document Issues, KPI, and metrics) throughout the lifecycle of an assigned study
• Assist in monitoring and tracking clinical trial progress and providing status update reports and study metrics
• Assist in the planning and/or facilitating TMF Strategy Meetings, Vendor/CRO Meetings, TMF Educational Workshops/training, and investigator meetings and making presentations, as required
• Stay abreast of current FDA, MHRA, EMA, PDMA, and other local regulations relevant to clinical and regulatory document creation, processing, management, and archival
• Support Inspection preparation activities – as required
• Prepare meeting agendas and minutes