Senior Clinical Trial Manager

Role Summary

Senior Clinical Trial Manager with a passion for new cancer therapy development. Responsible for independently leading the Study Execution Team (SET) and providing oversight of clinical trials for IDEAYA’s clinical programs. Works with cross-functional representatives to ensure successful completion of all clinical activities and project deliverables.

Responsibilities

• Lead/support SET to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines with minimal supervision
• Collaborate with SET to develop, review and facilitate RFPs, and contribute to bid defense meetings to select CROs and other clinical vendors
• Manage CROs and/or other clinical vendors to ensure project and corporate goals are achieved on time and within budget
• Lead development and review of key clinical documents (protocols, ICFs, CRFs, study reference manuals, study plans)
• Oversee study budgets and contracts, forecast financials with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work orders and changes
• Participate in implementation and oversight of clinical systems (CTMS, TMF, EDC, IRT)
• Clinical data review of data listings and summary tables, including query generation
• Oversee site management with CRO (monitoring reports, quality metrics)
• Lead additional study activities (site selection, start-up, recruitment, protocol deviation, TMF review)
• Review and track key study metrics; anticipate obstacles and implement creative solutions to meet goals and timelines
• Communicate study status and issues to Clin Ops management and stakeholders
• Risk management: identify risks, propose mitigations, and drive implementation with stakeholders
• Maintain relationships with internal teams, CROs, vendors and site personnel for successful trial execution
• Remove executional barriers with cross-functional stakeholders to meet timelines and goals
• Drive cross-functional decision-making with clear communication once consensus is reached
• Escalate and drive closure of issues raised by Clin Ops, stakeholders, vendors and partners
• Train investigators, site staff, vendors and team members on study protocol and trial conduct processes
• Ensure trials are inspection-ready and participate in QA/regulatory inspections as needed

Qualifications

• Bachelor‚Äôs in life sciences or related discipline; 8‚Äì10 years in clinical and drug development
• Advanced knowledge of domestic/global clinical study management and vendor management in oncology; interpretation and implementation of FDA and ICH/GCP regulations
• Early phase oncology trial management experience; precision medicine trials preferred
• Self-motivated, continuous improvement mindset, innovative ideas
• Results-oriented team player with strong collaboration and relationship-building skills
• Detail-oriented, creative thinker with a passion for process optimization
• Excellent organizational, analytical and communication skills (verbal and written)
• Ability to analyze and triage problems, prioritize and propose solutions
• Ability to travel up to 40%

Skills

• Clinical trial planning and execution
• Vendor and budget management
• Regulatory compliance (FDA, ICH/GCP)
• Cross-functional collaboration
• Data review and management (CRFs, data listings, query generation)
• System proficiency (CTMS, TMF, EDC, IRT)

Education

• Bachelor‚Äôs degree in life sciences or related discipline

Additional Requirements

• Onsite; ability to work four days per week at South San Francisco, CA