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Associate Director
2 months ago
Responsibilities Lead the Clinical Systems function, acting as a subject matter expert (SME) and system administrator for Clinical Operations systems. Accountable for partnering internally and externally to implement and maintain high quality, efficiently designed, clinical systems including the eTMF and CTMS.Own all aspects of Veeva eTMF/CTMS and applicable analytics tools including system administration, training, SOPs, storage, etc. Ensure that the eTMF/CTMS are always inspection ready; partner with Quality to ensure Part 11 compliance for all relevant supported systems; act as the SME for inspections and audits of eTMF and CTMS. Serve as a technical liaison to internal and external stakeholders for escalated system issues; ensure eTMF/CTMS are fully utilized and current. Lead systems vendor selection and perform ongoing service provider management and oversight of clinical system vendors. Monitor key performance indicators (KPIs) and conduct analysis to identify root causes for issues and recommends process improvements. Partner cross-functionally to develop and implement relevant Clinical Systems trainings, processes, and procedures. Evaluate emerging trends, technologies, and best practices and provides recommendations and direction on strategic roadmaps.
Qualifications BS/BA degree in related discipline with 7+ years of related clinical operations and clinical systems experience in biotech/pharma.Extensive experience working with Veeva Vault eTMF and CTMS.Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies to the larger organization and drive strategic changes needed by the business. Experience in clinical trial planning and execution strongly preferred.Computer validation knowledge and experience.Mastery of global regulatory requirements and guidelines for managing eTMF.Understanding of resource management and organizational capacity.Knowledgeable with the processes and principles of program and customer relationship management. Up-to-date knowledge of Clinical Operations processes and Information Systems. Analytical problem-solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root-causes. Expertise managing third party vendors in delivering service as expected. Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience. Excellent stakeholder management skills coupled with influencing and negotiation skills.
Working conditions & physical requirementsTravel may be required. Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
CompensationThe salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.The anticipated salary range for this role is $150,000 to $180,000 per year.
