SCI Senior Director, Clinical Operations (Hybrid)

About the role

The Senior Director, Clinical Operations leads the SCI-CTO clinical research operations organization by managing and overseeing all aspects of adult and pediatric clinical trials planning, study coordination and data management. This position is responsible for building and overseeing a team of highly skilled research staff to assure compliance with regulatory agencies, provide timely patient access to clinical trials; ensure data integrity and protocol adherence. This position collaborates closely with physician investigators and clinical research staff to drive successful implementation of cancer clinical trials.

Responsibilities

• Determine staffing levels, select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
• Determine staffing levels, select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
• Identify, clarify, and resolve issues with strategic impact and substantial significance, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge requiring broad discretion and judgment.
• Implement and maintain quality control standards, and evaluate program effectiveness.
• Collaborate with Stanford Medicine leaders on the direction of clinical research and operational objectives.
• Develop strategies to ensure effective achievement of objectives (both short and long term).
• Serve as a liaison to external organizations/agencies.
• Maintain compliance with regulatory requirements for participation in clinical research.
• Monitor affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research.
• Manage operational budget, assign resources within budget constraints, secure resources for new initiatives, report on financial health of operations.

Qualifications

• Demonstrated leadership experience of clinical trials and research teams.
• Oncology clinical operations experience.
• Academic clinical research experience.
• Advanced degree in nursing or other relevant fields preferred.
• Demonstrated experience building, leading, motivating, and managing a high performing team comprised of multiple position and experience levels.
• Advanced knowledge and understanding of concepts, policies and processes, and regulatory requirements associated with the development, implementation, and administration of multi-site or large-scale clinical trials and complex projects.
• Experience in adherence to GCP and other federal, state, and local regulations pertaining to human subject research.
• Knowledge of policies and regulations relevant to clinical trial management systems, electronic medical records, and clinical research billing practices.
• Strong attention to detail and organization with the ability to manage large volumes of information and competing priorities.
• Demonstrated ability to interact with and influence internal and external stakeholders with excellent independent judgment and decision-making skills.
• Demonstrated leadership, mentoring, training, planning, and change management skills.
• Demonstrated expertise in project management and analytical problem solving, with strong interpersonal, critical thinking, and communication skills.
• Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
• Demonstrated analytic and critical thinking skills, writing skills, communication skills and consulting skills.
• Clinical Research Certification (SoCRA, ACRP, or equivalent) preferred.
• Advanced Practice Provider (APP) certification preferred.