Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Associate Director, Site-Based Research
Job Number: 89254
The vision of the Stanford Center for Clinical Research (SCCR) is to transform human health. Growth at SCCR has been exponential since its inception six years ago. Many collaborations exist throughout the Department of Medicine, School of Medicine, and University.
SCCR seeks a Clinical Trials Operations Manager 2 (CTOM 2) to direct operational planning and clinical research activitiesincluding single- and multi-site studies, digital health, decentralized clinical trials, Data Safety Monitoring Boards, and Clinical Event Committees. The ideal candidate will have significant expertise in all or most of these activities, along with experience conducting research in many therapeutic areas. This position will oversee multiple clinical research operations leaders.
The CTOM 2 will also be responsible for building and strengthening collaborations with faculty throughout Stanford University, including VIP Directors, Chiefs, Chairs, and Associate Deans. Exceptional interpersonal, communication, and diplomacy skills are essential. This position will partner with faculty and SCCR staff to provide overall research operations guidance, which may include helping to shape complex budgets and protocols and proactively assessing resource needs to ensure alignment with talent, efficient operations, quality, and compliance.
Forging strong partnerships with Hospital and SoM leaders is an essential responsibility. The CTOM 2 will also develop strategic alliances with government agencies, industry sponsors, and foundations to negotiate new and repeat awards. Additionally, the CTOM 2 is responsible for collaborating with research operations and financial stakeholders to ensure feasibility and financial sustainability for research projects.
This critical position will be on SCCR's executive leadership team, and will help guide and implement strategic initiatives to ensure achievement of the vision. The CTOM 2 will also be a guardian of SCCR's core values, which include a commitment to collaboration; excellence; respect; life/work balance; fun; and diversity, equity and inclusion.
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.
*- The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
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.
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 any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Occasional local and overnight travel.
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.
Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
Discovery and fun. Stroll through historic sculptures, trails, and museums.
Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
*- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Additional Information
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.