Clinical Trial Operations Manager, Coordinating Center

Location
California, United States
Posted
14 Feb 2019
End of advertisement period
14 Apr 2019
Ref
81952
Contract Type
Permanent
Hours
Full Time

The Stanford Center for Clinical Research (SCCR) seeks an Associate Director, Coordinating Center for our rapidly growing academic research organization within the Stanford Department of Medicine at Stanford University. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health. We work closely with health tech, device and pharmaceutical companies; interest and experience collaborating with industry and digital health stakeholders is crucial.

We seek a mission-driven Associate Director, Coordinating Center to oversee the strategy, operational planning and activities for all clinical research conducted in our Coordinating Center. Examples of research projects you will oversee include the Apple Heart Study, which recently enrolled more than 400,000 participants nationally; and a community-based athletic studies project for concussion research that is being conducted in partnership with Bioengineering and the Department of Neurosurgery at Stanford. You will also oversee staff and partner with faculty and colleagues who work on Clinical Event Committees and Data Safety Monitoring Boards. 

You will lead a high-performing team of a dozen staff, and directly supervise multiple clinical research managers. Responsibilities also include ensuring compliance with GCPs and SOPs, and collaborating with finance, quality, education and business development managers. You will collaborate closely with leadership to cross-train and create an infrastructure to ensure we can be nimble when needed and that resources can accommodate the natural ebbs and flow of research projects.

The ideal Associate Director, Coordinating Center has significant experience leading multi-site and digital health clinical research projects. You will also have exceptional interpersonal, communication and diplomacy skills. Additional qualifications include the ability to build and strengthen relationships with internal, multidisciplinary Stanford faculty and staff, and external VIP sponsors—and to shape proposals for industry and government sponsors. You will also have financial experience in creating, negotiating and managing multi-million dollar project budgets. High integrity, and a commitment to excellence and continuous improvement is essential.

At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work, and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply!
Learn more about our work and core values: www.med.stanford.edu/sccr

Duties include:

  • 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
  • Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Relevant graduate degree and ideally seven to 10 years of experience in clinical research.

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.

PHYSICAL REQUIREMENTS*:

  • 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.

WORKING CONDITIONS:

Occasional local and overnight travel.

WORK STANDARDS:

  • 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.

Job Family: Research
Job Series: Clinical Trials Operations Manager
Job Code: 4937
Grade: L
Exemption: Exempt
Schedule: Full-time