Senior Clinical Trial Manager/Clinical Trial Manager at Fate Therapeutics Inc in San Diego, CA

Job description

• Fate Therapeutics is seeking a Clinical Trial Manager or Senior Clinical Trial Manager to lead complex clinical studies from start-up through close-out, ensuring high-quality execution, strong site and vendor partnerships, and timely delivery of key milestones. This role is ideal for a highly organized and proactive clinical operations leader who is motivated to advance innovative therapies in oncology and/or autoimmune disease. The successful candidate will bring hands-on clinical operations experience, sound judgment, and the ability to lead cross-functional teams, solve problems proactively, and communicate clearly in a fast-paced environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Independently lead complex or high-risk clinical trials from start-up through close-out, including study team leadership, timelines, enrollment strategy recommendations, risk mitigation, and completion planning.
• Ensure study deliverables are completed on time, within budget, and in compliance with GCP/ICH requirements, company SOPs, and applicable quality standards.
• Manage study budgets, forecasts, projections, invoice review and approval, and vendor spend in partnership with Finance and Clinical Operations.
• Lead site identification, evaluation, qualification, initiation, monitoring, booster visits, and close-out; partner with investigators, site staff, and field personnel to support study conduct and timely data collection.
• Develop and oversee enrollment strategies, monitoring plans, source document verification, data review, cleaning, freeze readiness, and data quality activities.
• Manage clinical vendors, including RFI/RFP support, vendor evaluation, selection, oversight, issue resolution, and performance management.
• Oversee Trial Master File implementation and maintenance to ensure ongoing inspection readiness.
• Drive development, review, and approval of study documents and tools, including protocols, informed consent forms, budgets, monitoring reports, project plans, logs, templates, newsletters, and operational materials.
• Provide concise study updates, reports, risks, and issues to senior management; escalate concerns promptly with recommended solutions.
• Provide oversight, training, mentoring, delegation, and dotted-line management, as applicable, for CTMs, CTAs, CRAs, and assigned clinical trial staff.
• Develop and deliver study training for investigators, site staff, and internal teams; support study supplies management and related operational processes.
• Support internal process, vendor, and site quality audits and regulatory inspections, including preparation, participation, and follow-up.
• Lead or participate in internal and external study meetings, Investigator Meetings, iDMC meetings, conferences, and events.
• Develop SOPs, best practices, and process improvements to strengthen clinical trial execution.

Requirements

• B.S. degree with at least 6 years of clinical trial management experience in a biotech, pharmaceutical, and/or CRO environment.
• Strong clinical operations expertise, including end-to-end study conduct from start-up through close-out, global trial execution, and CRO/vendor management.
• Highly organized and self-directed, with the ability to manage multiple priorities, meet deadlines, and work with minimal supervision.
• Oncology, autoimmune, or cell therapy experience highly preferred.
• Working knowledge of FDA/ICH guidelines, Good Clinical Practice, clinical trial initiation and management practices, and pharmaceutical and clinical development processes.
• Demonstrated leadership, decision-making, problem-solving, and cross-functional study team management skills.
• Ability to engage, influence, and collaborate effectively across matrixed organizations and with external partners, including investigators, clinical sites, and vendors.
• Excellent communication skills and professional demeanor; able to work effectively with medical personnel, clinical monitors, statisticians, data managers, medical writers, and internal cross-functional partners.

Skills

Required

• Clinical trial management
• Clinical operations
• CRO/vendor management
• FDA/ICH guidelines
• Good Clinical Practice
• Leadership
• Decision-making
• Problem-solving
• Cross-functional team management
• Communication
• Collaboration

Preferred

• Oncology experience
• Autoimmune experience
• Cell therapy experience

Benefits

• 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 $135,000 - $180,000.
• 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.