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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