Clinical Systems Director
2 weeks ago
Fate Therapeutics is seeking a highly skilled Clinical Systems Director to lead the operational leadership and oversight of the clinical systems function within Clinical Operations. This key contributor will be responsible for overseeing the electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).
Key Responsibilities
Lead the Clinical Systems function, acting as a subject matter expert (SME) and system administrator for Clinical Operations systems.
Partner 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.
Requirements
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.
About Fate Therapeutics
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products.
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