Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. The Director of Clinical Research Associates (CRAs) is responsible for leading and scaling the CRA organization to support a growing clinical development portfolio, ensuring quality, efficiency, and compliance across all clinical trials.

Responsibilities

• Develop and execute a scalable CRA organizational strategy to support company growth
• Balance and optimize the use of internal CRAs (FTEs) and contract resources to meet evolving study demands
• Lead clinical monitoring operations using risk-based monitoring (RBM) principles to improve quality and operational efficiency
• Oversee resource forecasting, capacity planning, and allocation across multiple clinical programs
• Implement and leverage software and technology solutions for managing field-based CRA performance, productivity, and travel
• Partner closely with Clinical Operations, Clinical Development, Data Management, and Quality to ensure effective study execution
• Establish metrics, KPIs, and performance management processes for the CRA organization
• Recruit, mentor, and develop CRA leaders and staff while fostering a culture of accountability and continuous improvement
• Other duties as assigned

Skills

• Bachelor's degree in life sciences discipline
• 10+ years of clinical operations experience, including 5 years leadership of CRA teams within a biotechnology or pharmaceutical company
• Demonstrated success scaling a clinical monitoring organization during periods of rapid growth
• Deep expertise in risk-based monitoring methodologies and ICH-GCP
• Experience balancing internal and outsourced monitoring resources, including vendor oversight and contractor management
• Strong experience with clinical resource forecasting, workforce planning, and capacity management
• Familiarity with software platforms used to manage field-based staff, resource planning, and clinical monitoring operations
• Excellent leadership
• Communication
• Problem-solving
• Collaboration
• Time management
• Attention to detail
• Advanced degree preferred

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