The Senior TMF Specialist is a key role at Cytokinetics, responsible for overseeing the management and quality control of Trial Master File (TMF) documentation across multiple studies. This role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to study teams and TMF Document specialists. The Senior TMF Specialist will also play a key role in inspection readiness, process improvement, and training initiatives. The Senior TMF Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, and Regulatory Affairs, to ensure the accuracy, completeness, and timeliness of TMF documentation.

TMF Document Management & Oversight

• Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements.
• Lead milestone TMF reviews, ensuring that all required documents are accurately filed and accessible.
• Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.
• Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues.
• Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community.
• Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible
• Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment.

Study Team Support

• Act as a senior liaison between the TMF Manager, TMF Document Specialist, vendors, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle.
• Collaborate with internal stakeholders to gather and provide critical information needed to execute the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with the Study-Specific TMF Plan and TMF Index.
• Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues.
• Mentors TMF Document Specialist by providing guidance on essential document attributes, such as document classification and resolution of document queries. Furthermore, advises study team members on the best practices in document management.

TMF Metrics & Reporting

• Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement.
• Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes.
• Provide regular TMF/eTMF status updates during Clinical Vendor Oversight Meetings and Study Operational Team meetings.

Inspection Readiness

• Ensure the TMF complies with all applicable regulatory requirements and guidelines.
• Prepare for and support regulatory inspections and audits related to the TMF.

Qualifications

• Bachelor’s Degree Required
• 3+ years of Veeva Vault eTMF experience required.
• 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience with global clinical trials is highly desirable.
• TMF Certification or TMF training optional but preferred (e.g., DIA’s TMF Certificate Program or LMK TMF University) or other relevant certifications.

Key Skills, Abilities, and Competencies

• Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.)
• Experience in managing TMF documents during regulatory inspections.
• Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements.
• Basic understanding of study and site management and overall trial planning and execution.
• Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations
• Familiarity with MS Word, MS Excel (extra plus), and MS PowerPoint.

Core Competencies

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Tolerance of ambiguity and willingness to work through complex issues.
• Strong work ethic, organizational skills, oral and written communication skills, a ‘can do’ approach, problem-solving skills, and team player skills.
• 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.