Stanford University is seeking a Senior Clinical Research Manager to provide leadership and oversight of complex large or multiple small clinical research projects. Supervise multiple clinical research staff, leads, managers. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. Mentor Clinical Research Managers.
Stanford University is one of the world’s most renowned universities. Sitting in the heart of the San Francisco Bay Area among the valley’s most progressive companies.
You will be working with an unparalleled leading-edge community of faculty and staff that are fundamentally changing the world of health care. You will have the opportunity to influence and drive change with your innovative ideas, the ability to make a difference and participate in human advancements. Our culture is fast-paced, energetic, and growing all of the time.
We offer a variety of benefits beyond traditional medical, dental, retirement, and savings options:
- Events and program for children, sports camps, tuition options
- World-class intellectual stimulation through learning and development classes, workshops, and onsite conferences from leading-edge speakers and faculty
- Work/life and family-friendly policies and reimbursement
- Participation in Stanford’s social responsibility and sustainable programs for a better world
- A vibrant university culture that values the uniqueness of each individual
We are seeking candidates who are progressive thinkers, see challenges as simply problems to solve, and have the spirit and energy to change the world.
About the Department of Pathology:
The Department of Pathology at Stanford School of Medicine, one of its founding departments, stands as a leader among its peers nationwide. Our preeminent faculty spans from emerging leaders to highly accomplished physicians and scientists, including a Nobel laureate and members of the National Academy. Our mission is to improve the diagnosis, treatment, and basic understanding of the human disease. This is done through discovery (research), education, and clinical care.
Comprised of extraordinary faculty and staff, our mission is to improve the ability to diagnose, treat and understand the origin and manifestation of human disease, and to care for those who have or are at risk to develop disease. We accomplish this through our clinical services (in all fields of anatomic and clinical pathology, including molecular and genomic pathology, histocompatibility testing and transfusion medicine) and research (which includes basic, translational and clinical research into the origins and manifestations of disease, including efforts to improve disease prediction and prevention as part of the goal of achieving precision medicine and health), and also by educating future leaders in pathology and related fields. Everything we do is to achieve the goals of providing the highest quality of clinical services to the patients for whom we passionately care, to advance our ability to understand, diagnose, monitor and ultimately to cure disease or to prevent or delay its occurrence, and to provide outstanding education and career development opportunities to those who share these goals.
About the Center:
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is the first of its kind, dedicated to advancing treatments and discovering underlying immune mechanisms to develop lasting cures for allergies and asthma in both children and adults. Our interdisciplinary team of leading scientists, physician-scientists, and specialists from fields such as immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics collaborates on cutting-edge research aimed at understanding immune dysfunction that leads to allergic reactions.
Through laboratory and computational research, clinical trials, and community outreach, we are committed to developing rational, evidence-based therapies that provide the safest and most effective treatments for patients. By combining innovative science with compassionate care, we strive to transform lives at both local and global levels.
About the Position:
The Sean N. Parker Center for Allergy and Asthma Research is seeking a Senior Clinical Research Manager to provide management of the operations and research for the clinical research unit. Achieve mission goals through the management of clinical research staff in developing, advancing and applying science, engineering and technology. The Clinical Research Unit is composed of 20 FTEs (Clinical Research Coordinator teams, data team, Research Nurses, and a regulatory specialist. The Center is located within the School of Medicine’s Department of Pathology.
Duties include:
- Select, develop, and evaluate personnel to ensure efficient operations, including hiring, performance management, and related duties. Oversee staffing and overall resourcing for program(s) under purview. Mentor Clinical Research Managers.
- Audit operations to ensure effective implementation of internal processes and quality program. Provide leadership in identifying and implementing corrective actions/processes. Lead inspections or audits.
- Oversee development of effective participant recruitment and retention activities. Oversee development of regulatory documents, including consent forms, for studies.
- Make strategic decisions regarding new and existing clinical research projects that may impact resourcing, quality, safety and/or compliance of program(s) under purview. Lead or chair committees or task forces to address and resolve significant issues.
- Develop and/or implement research goals for a clinical trial(s)/ therapeutic program in collaboration with multiple faculty members and internal/external stakeholders.
- Oversee regulatory management of programs and troubleshoot complex regulatory issues. Mentor and train managers and staff on how to resolve compliance issues and regulatory challenges across programs/organizations.
- Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct. Lead process and quality improvement initiatives to ensure efficiency in implementation of new protocols.
- Manage and track research program financial status with regular reports to research leaders. Oversee development of appropriate study budgets that meet the needs of the research program.
- Engage in high-level outreach and networking opportunities in a program leadership capacity, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment across the portfolio, develop and monitor use of standardized reporting of key metrics. Develop ideas and implement improved processes and tools to ensure program success and compliance.
- Contribute to analysis of data and preparation of manuscripts and scientific presentations.
*Other duties may also be assigned
Desired Qualifications:
- Knowledge of hypothesis-generating (omics) and experience in hypothesis-testing scientific research projects
- Knowledge and experience including General clinical experience Good Clinical Practices and Conduct of Clinical Research Studies
- Ability to run a high-quality research organization, organizing and motivating teams who perform basic science research and clinical research
- Experience developing and nurturing a growing organization, mentoring managers and project leaders, implementing processes, quality control mechanisms to ensure consistency across groups
- Experience with improving quality, implementing metrics, and reporting results
- Proven track record of successfully implementing clinical research studies from start to finish
- Experience in grant writing and securing funding for research projects
- Prior experience managing a large team in a clinical research environment
Education & Experience (Required):
- Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
Knowledge, Skills and Abilities (Required):
- Excellent interpersonal skills.
- Excellent diplomacy skills.
- Proficiency in Microsoft Office and database applications, and EHRs (i.e., REDCap Cloud, EPIC).
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology.
- Minimum of three years of demonstrated managerial experience.
- Demonstrated disease knowledge / study design experience of studies under purview.
Certifications & Licenses:
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Physical Requirements:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
- - 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:
- May be exposed to blood borne pathogens.
- May be required to work non-standard, extended or weekend hours in support of research or project work.
- This position may have a flexible work location, with the possible ability to be either co-located near the Stanford campus in Palo Alto, CA as a hybrid worker.
Why Stanford is for You
