Clinical Trials Regulatory Manager
Job Code: 4944
Job Grade: J
Stanford University is seeking a Clinical Trials Regulatory Manager to be responsible for leading the administration and regulatory compliance of clinical research within the university on behalf of a department or/and institute, and representing the university with external regulatory agencies, both domestic and international.
- Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects.
- Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics.
- Lead efforts, authorize and manage submissions to internal and external agencies. Provide final review and approval for submissions and reports.
- Hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.
- Oversee, develop and facilitate educational and compliance training programs.
- Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.
- Serve as a regulatory point of contact during audits. May act on behalf of Senior Management in regard to interactions with regulatory agencies.
- Represent department or institute in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the National Institutes of Health.
- Interact and advise senior management on clinical trials regulatory processes or decisions.
- May have budget responsibility for day to day operations.
* - Other duties may also be assigned
- Experience developing, writing and maintaining standard operating procedures (SOPs) and other quality documents
- Experience teaching regulatory principles, concepts and operational information
- Experience with quality monitoring and/or auditing clinical research studies
- Experience with process excellence processes and evaluation
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor’s degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience in clinical research management and oversight, including project management in a dynamic research setting.
- Experience in a lead role and interactions with federal agencies, i.e. FDA.
- Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice.
- Knowledge of International Conference on Harmonization (ICH) standards.
- Experience in developing and implementing multifaceted projects.
- Excellent communication and organizational skills and superb attention to detail.
- Experience with MS Office products and database applications required.
- Strong written and verbal skills.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally sit, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- May require occasional local and overnight travel.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.