Associate Director Clinical Operations
Stanford University is seeking a Clinical Trials Operations Manager 2 to direct the overall operational planning and activities for the entire clinical trials operations for the Cancer Clinical Trials Office, with a focus on Pediatrics. Typically supervises Clinical Trial Operations Manager 1 and/or Managers of functional areas related to the research (i.e. Quality Assurance; Regulatory).
- Contribute to strategy and direction to establish objectives for the overall operation for a clinical trials organization. Lead implementation of strategy for organization.
- 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.
- Negotiate with internal departments and external agencies (FDA, NIH, Hospitals) with authority to commit resources and effort.
- Collaborate with Hospital and SoM leadership 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. Negotiate and establish external resource contracts.
- Participate in the evaluation and submission of grant applications in support of clinical research infrastructure and operations for multiple trials.
- 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.
* - Other duties may also be assigned.
- Master’s in Business, Management, Nursing, Public Health or related field
- Senior level management skills with experience developing strategies and leading the administrative and financial operations of a large organization to implement tactical programs in support of the strategies, preferably in a National Cancer Institute-designated cancer center, other large academic clinical research program such as a CTSA, hospital unit, or in an industry-based clinical research organization.
- Proficiency in Microsoft Office and database applications.
- Excellent written, verbal, interpersonal, and presentation skills. Ability to communicate effectively with scientific, medical, professional, executives, administrative, and other personnel at all levels of an organization. Ability to build relationships and enable effective communications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices.
- Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies. Additionally, the Associate Director should be familiar with insurance billing, and the Medicare Coverage Act.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus eight years of relevant experience or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Demonstrated experience leading and managing staff and/or managers.
- Demonstrated experience leading multi-site or large-scale clinical trials research.
- Management experience with developing strategies and leading the administrative and financial operations of a large organization academic or industry-based clinical research organization.
- Demonstrated ability to interact and influence internal senior leadership and external stakeholders.
- Demonstrated leadership, planning and change management skills.
- Strong knowledge of industry standards and/or regulatory requirements.
- Demonstrated expertise in project management, analytical problem solving, and negotiating experience.
- 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.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally stand, 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
WORKING CONDITIONS:any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- Occasional local and overnight travel.
WORK STANDARDS (from JDL):
- Ensure consistency and adherence to clinical research guidelines, compliance with good clinical practices, good manufacturing practices and regulatory guidelines.
- 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.