Contract - Senior Trial Master File (TMF) Specialist
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About The Position
The Senior TMF Specialist is a pivotal role at Cytokinetics, tasked with the oversight and quality control of Trial Master File (TMF) documentation across various studies. This position requires a strong leadership presence in document management processes, ensuring that all activities comply with regulatory requirements while providing expert guidance to study teams and TMF Document specialists. The Senior TMF Specialist is integral to maintaining inspection readiness, driving process improvements, and spearheading training initiatives. Collaboration is key, as this role involves working closely with cross-functional teams, including Clinical Operations, Quality Assurance, and Regulatory Affairs, to guarantee the accuracy, completeness, and timeliness of TMF documentation. In terms of TMF Document Management & Oversight, the Senior TMF Specialist will strategically manage the document lifecycle within Veeva Vault eTMF. This includes overseeing the creation, version control, review, approval, and archival of documents, ensuring that all activities align with study timelines and regulatory requirements. The role also involves leading milestone TMF reviews to ensure that all necessary documents are accurately filed and easily accessible. The Senior TMF Specialist will proactively identify and address potential compliance risks, lead efforts to resolve document inconsistencies, and work with functional areas to implement corrective actions to prevent future issues. Additionally, the role includes identifying trends in eTMF management and leading targeted training sessions for the TMF Community. As a Study Team Support, the Senior TMF Specialist acts as a senior liaison between the TMF Manager, TMF Document Specialist, vendors, and study teams, providing expert guidance on TMF documentation requirements throughout the study lifecycle. This includes collaborating with internal stakeholders to gather critical information needed to execute the Expected Document List (EDL) requirements and ensuring alignment with the Study-Specific TMF Plan and TMF Index. The Senior TMF Specialist serves as the Subject Matter Expert (SME) for TMF documents, offering consultation on complex document management issues and mentoring TMF Document Specialists on essential document attributes. In terms of TMF Metrics & Reporting, the Senior TMF Specialist will lead the monitoring of TMF processing metrics, ensuring timely processing, review, and submission of documents. This role involves using data-driven insights to identify areas for improvement and tracking key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Regular updates on TMF/eTMF status will be provided during Clinical Vendor Oversight Meetings and Study Operational Team meetings. Finally, the Senior TMF Specialist is responsible for ensuring that the TMF complies with all applicable regulatory requirements and guidelines, preparing for and supporting regulatory inspections and audits related to the TMF.
