Senior Clinical Trial Manager/Clinical Trial Manager

Fatetherapeutics; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Fate Therapeutics is seeking a Clinical Trial Manager or Senior Clinical Trial Manager to lead complex studies from start-up through close-out at our San Diego headquarters. You will drive cross-functional collaboration, manage budgets and vendors, and ensure compliance with GCP/ICH standards.

The role requires hands-on clinical operations leadership, problem-solving, and proactive communication in a fast-paced environment.

Qualifications

• Experience leading complex clinical trials from start-up through close-out.
• Strong understanding of GCP/ICH requirements and SOPs.
• Ability to manage budgets, vendors, and cross-functional teams.

Responsibilities

• Independently lead complex or high-risk clinical trials from start-up through close-out.
• Ensure study deliverables are on time, within budget, and compliant with GCP/ICH requirements and SOPs.
• Manage study budgets, forecasts, invoices, and vendor spend in partnership with Finance and Clinical Operations.
• Lead site identification, initiation, monitoring, and close-out; collaborate with investigators and site staff.
• Develop enrollment strategies, monitoring plans, data quality activities, and source data verification.
• Manage clinical vendors including RFI/RFP, evaluation, oversight, and issue resolution.
• Oversee Trial Master File implementation and inspection readiness.
• Drive development and approval of study documents and tools (protocols, ICFs, budgets, reports).
• Provide concise study updates, risks, and issues to senior management with recommended solutions.
• Provide mentoring and supervision for CTMs, CTAs, CRAs, and assigned staff.

Skills

Cross-functional leadership

GCP/ICH

Vendor management

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; escalation 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