Fate Therapeutics
Associate Director / Senior Manager, Clinical Systems
Fate Therapeutics, San Diego, California, United States, 92189
Fate Therapeutics is looking for an Associate Director or Senior Manager, Clinical Systems. This key contributor will be responsible for the operational leadership and oversight of the clinical systems function within Clinical Operations, including overseeing the electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). The successful candidate will ensure the consistent use and application of technology and standards, ensuring complete and accurate documentation and management of study data across all programs. This is a full-time position located at our corporate headquarters in San Diego, CA.
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 recommend process improvements.Partner cross-functionally to develop and implement relevant Clinical Systems trainings, processes, and procedures.Evaluate emerging trends, technologies, and best practices and provide 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 the ability to define problem statements 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 the pharmaceutical or Biotech industry with clinical drug development experience.Excellent stakeholder management skills coupled with influencing and negotiation skills.Working conditions & physical requirements
Travel may be required.Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation
The 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.
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.Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online
Privacy Notice .About Fate Therapeutics, Inc.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. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit
www.fatetherapeutics.com .
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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 recommend process improvements.Partner cross-functionally to develop and implement relevant Clinical Systems trainings, processes, and procedures.Evaluate emerging trends, technologies, and best practices and provide 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 the ability to define problem statements 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 the pharmaceutical or Biotech industry with clinical drug development experience.Excellent stakeholder management skills coupled with influencing and negotiation skills.Working conditions & physical requirements
Travel may be required.Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation
The 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.
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.Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online
Privacy Notice .About Fate Therapeutics, Inc.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. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit
www.fatetherapeutics.com .
#J-18808-Ljbffr