We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular and neuromuscular diseases of impaired muscle function.

As the TMF Manager Consultant, your role will oversee the day-to-day operations of study-specific TMF management. This includes providing subject matter expertise and Clinical Operations Team support required to ensure the Trial Master File is inspection ready for appropriate studies at Cytokinetics.  Your role and responsibilities are pivotal as the point of contact to the Clinical Operations team as well as outside contract research organizations used. 

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

Qualifications

• 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.

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.