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 Stanford's Department of Medicine, School of Medicine, and University.
SCCR seeks a Clinical Trials Operations Manager 1 (CTOM 1) to oversee multiple small and large portfolios, such as the Clinical Event Committee, Hospital Medicine, ValleyCare, Decentralized Clinical Trials, and potentially new collaborations across the University as demands increase. The ideal candidate will have significant expertise in leading complex clinical trials with industry and government sponsors, along with experience conducting research in many therapeutic areas. This position will oversee multiple clinical research managers and project managers.
The CTOM 1 will help build and strengthen collaborations with faculty throughout Stanford University. Exceptional interpersonal, communication, and diplomacy skills are essential. This position will collaborate with faculty liaisons and SCCR staff to provide research operations leadership and mentorship, which includes guidance on pre-award activities with internal and external stakeholders to ensure appropriate resources; ensuring staff engagement, quality and compliance; great participant experiences; and exceeding PI and sponsor expectations.
Additionally, the CTOM 1 is responsible for collaborating with research operations and financial stakeholders to ensure feasibility and financial sustainability for research projects. The CTOM 1 will identify and oversee the implementation of Process Excellence initiatives to improve efficiencies across clinical research operations. Additional responsibilities include building and strengthening an agile operations framework, which will include backup planning, and proactively identifying matches of needs, talent, and education. This critical position will be on SCCR's leadership team, and will help shape and implement strategies to achieve our vision and mission. The CTOM 1 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.
Make decisions regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.
Select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
Provide direction to PI's, Clinical Research Managers on staffing needs, funding and resources in order to meet the needs of individual research efforts and overall research group.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.
Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
Liaise with senior management ad cross functional areas and schools. Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
Manage and coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of actives that meet objectives of assigned research protocol(s).
Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
Administer the budget, assign resources accordingly and assist with grant budget proposals.
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.
Graduate degree and at least 10 years of highly relevant experience leading complex clinical research operations.
Clinical research operations certificate from ACRP, SOCRA, or Stanford's CROP.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing clinical trial staff.
Demonstrated experience leading multi-site or large-scale clinical trials research.
Ability to run a high quality clinical research organization, organizing and motivating teams to follow good clinical practice and regulatory requirements, while providing excellent patient care and study conduct.
Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
Project management experience in a research environment.
Strong knowledge of industry standards and/or regulatory requirements.
Knowledgeable about insurance billing, and the Medicare Coverage Act.
Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
Excellent written, verbal, interpersonal, and presentation 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.
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 2021 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.