Senior Clinical Research Manager

$143,346 - $163,821/Yr

Stanford University - Stanford, CA

Full-time - Senior

Stanford, CA

10,001+ employees

Educational Services

About the position

The Senior Clinical Research Manager at Stanford University will lead and oversee complex clinical research projects, managing operations, quality assurance, personnel, regulatory compliance, and fiscal oversight. This role involves mentoring clinical research staff and ensuring the successful execution of clinical trials while contributing to the advancement of healthcare through innovative research.

Responsibilities

• Provide leadership and oversight of clinical research operations.
• Supervise multiple clinical research staff, including managers and leads.
• Manage quality management, personnel management, regulatory compliance, and fiscal oversight.
• Mentor Clinical Research Managers and staff.
• Audit operations to ensure effective implementation of internal processes and quality programs.
• Oversee participant recruitment and retention activities.
• Develop regulatory documents, including consent forms, for studies.
• Make strategic decisions regarding clinical research projects.
• Lead committees or task forces to address significant issues.
• Develop and implement research goals for clinical trials in collaboration with faculty and stakeholders.
• Oversee regulatory management and troubleshoot complex issues.
• Provide guidance on compliance with regulations on clinical research conduct.
• Manage and track research program financial status and develop study budgets.
• Engage in outreach and networking opportunities representing the research program.
• Analyze recruitment trends and develop standardized reporting metrics.
• Contribute to data analysis and preparation of manuscripts and presentations.

Requirements

• Bachelor's degree in a related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Minimum of three years of demonstrated managerial experience.
• Knowledge of Good Clinical Practices and conduct of clinical research studies.
• Experience with research protocols and regulatory bodies, including HIPAA and FDA regulations.
• Excellent interpersonal and diplomacy skills.
• Proficiency in Microsoft Office, database applications, and EHRs (e.g., REDCap Cloud, EPIC).
• Demonstrated disease knowledge and study design experience.

Nice-to-haves

• Master's degree in a related field.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification.
• Experience in grant writing and securing funding for research projects.

Benefits

• Medical, dental, retirement, and savings options.
• Events and programs for children, sports camps, and tuition options.
• Learning and development classes, workshops, and onsite conferences.
• Work-life and family-friendly policies and reimbursement.
• Participation in social responsibility and sustainable programs.