Clinical Trials Regulatory Manager
As part of the new Stanford University Center for Definitive and Curative Medicine (CDCM), the Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) provides comprehensive project support and clinical trial management resources to Stanford Investigators specializing in cellular and gene therapies. The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) seeks a Quality and Compliance Manager (CTRM) by contributing to the definition, implementation, and support of processes that build quality into clinical trial operations within the university on behalf of a department or/and institute, and representing the university with external regulatory agencies, both domestic and international.
The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
- Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure quality and compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects.
- Conduct audits of internal systems and regulatory submission documents, internal system/process audits. Ensure audit related corrective and preventative actions are taken.
- 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 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 FDA.
* - Other duties may also be assigned
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.
CERTIFICATIONS & LICENSES:
- Relevant certification in clinical research, GCP, and/or quality assurance.
- 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.
- Schedule: Full-time
- Job Code: 4944
- Employee Status: Regular
- Grade: J
- Department URL: http://pediatrics.stanford.edu/
- Requisition ID: 85883