Note: The job is a remote job and is open to candidates in USA. Arcus Biosciences is seeking a Senior Clinical Program Manager responsible for the strategic and operational leadership of complex clinical studies. This role ensures that clinical trials are executed on time, within budget, and in compliance with regulatory requirements, while also mentoring junior staff and contributing to program-level success.
Responsibilities
- Lead one or more complex or global clinical studies, providing strategic input into program planning and operational strategy
- Oversee day-to-day study management activities from start-up through close-out
- Anticipate operational risks and develop proactive mitigation and contingency plans
- Ensure consistency, quality, and inspection readiness across studies
- Lead cross-functional study teams to plan, implement, and execute clinical trials within agreed timeline, budget, and quality standards
- Serve as the primary operational contact for functional area representatives, CROs, service providers, and vendors
- Facilitate operational activities for Phases I–IV clinical trials, including submissions, study plans, study tools, and Investigator Meetings
- Manage key vendors; define, monitor, and act on performance metrics and KPIs
- Oversee CROs and service providers, including selection, study‑specific training, and ongoing performance oversight
- Participate in outsourcing activities and contribute to service provider evaluation
- Ensure compliance with ICH GCP, applicable regulations, protocols, and company SOPs
- Contribute to or review study-related documents such as protocols, IBs, CRFs, informed consent forms, and study plans
- Participate in and respond to Quality Assurance audits and regulatory inspections
- Support inspection readiness activities at the study and program level
- Establish and track study milestones; ensure accurate reporting of study status and metrics
- Prepare and manage study budgets and timelines, ensuring financial accountability and forecasting accuracy
- Recommend and implement process improvements and innovations to improve study quality and operational efficiency
- Serve as a subject matter expert for clinical operations processes, tools, and systems
- Mentor and develop junior staff, contributing to competency growth across the organization
- Build and maintain strong internal and external relationships to support clinical program success
Skills
- Bachelor's degree, preferably in a scientific field
- 8+ years of industry experience, with 7+ years of global study management experience at a Sponsor or CRO
- Demonstrated experience leading oncology, inflammation, or immunology clinical studies
- Strong leadership skills with proven experience managing cross-functional teams and vendors
- Excellent written and verbal communication skills
- Strong analytical, organizational, and problem-solving abilities
- Ability to manage multiple priorities in a dynamic environment
- Self-motivated, collaborative, and adaptable
- Proficiency with Microsoft Office and clinical trial systems (EDC, IRT, CTMS, eTMF, etc.)
- Ability and willingness to travel 10–20% domestically and internationally
Benefits
- The opportunity to participate in stock programs
- A performance-based bonus
- A comprehensive benefits package
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