Senior Clinical Trial Manager

Responsibilities

• Lead all aspects of assigned clinical trials, guiding a cross-functional study team while promoting accountability, collaboration, and high performance.
• Manage all components of high complexity or elevated risk, global, and/or pivotal trials.
• Proactively manage CROs, vendors, and clinical sites to ensure timely deliverables and adherence to study plans.
• Apply critical thanking and data-driven decision-making to proactively identify risks, implement mitigation strategies, and resolve issues with speed and precision.
• Drive development and implementation of study documents, including protocol, monitoring plans, informed consent forms, and training materials.
• Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements and Fate SOP.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Partner efficiently, effectively, and professionally with assigned Clinical Research Associates (CRA) and participate in study sites to ensure effective study conduct.
• Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
• Partner closely with Finance on study budget management, study budget forecast, vendor contracts and review/approve vendor and site invoices
• Responsible for the implementation and oversight of the Trial Master File (TMF), ensuring consistent, high-quality documentation to maintain inspection readiness at all times.
• Provide study updates and reports, inclusive of study risks and issues.
• Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, iDMC, and study management meetings.
• Responsible for ongoing study data reviews and data cleaning activities. 
• Oversee Clinical Trial Associate and Clinical Research Associate activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
• Manage trial-level quality risk management.
• Oversee study supplies management.
• Lead study training to investigators, site staff and internal staff on study processes.
• Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
• Lead on-site/remote site booster visits.

Qualifications

• B.S. degree with a minimum of 7 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
• Oncology or autoimmune experience required.
• Immunotherapy or cellular therapy experience preferred.
• Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out.
• Global trials or CRO management experience preferred.
• Management experience of project teams along with the ability to lead cross functional study teams.
• Exceptional critical thinking, problem-solving, and communication skills.
• Proven ability to navigate ambiguity, prioritize tasks effectively, and make confident decisions in a fast-paced setting.
• Critical thinking and problem-solving skills—ability to anticipate challenges, analyze risks, and drive resolution
• Strong written and verbal communication with the ability to lead cross-functional teams effectively
• Proactive, accountable, and results-driven with a collaborative mindset
• Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures.

Working Conditions & physical requirements

• Onsite work at corporate headquarters in San Diego, CA.  
• Travel may be required.  
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Compensation

• The salary offer will