Senior Clinical Research ManagerSchool of Medicine, Stanford, California, United StatesNewResearchPost Date 8 hours agoRequisition # 103407Stanford 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.The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is the first center of its kind, aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against the diseases and develop a lasting cure. Our interdisciplinary center focuses on understanding the mechanisms of the immune system, the dysfunctions of which results in allergic reactions. A leader in allergy research, our Center works collaboratively with other researchers around the world to create a data-sharing cluster of information from our interlinked satellite centers to run novel and innovative clinical trials in allergy research. Our Center includes Stanford specialists in diverse fields including immunology, gastroenterology, otolaryngology, chemistry, bioengineering, pathology, pulmonology, and genetics. Through laboratory and computational research, clinical trials, community outreach, and other efforts, the team works towards finding rationally-based therapies to provide the safest and best treatments for allergies and asthma. Research at the Center may have implications for a wide array of immune dysfunctions including asthma, eczema, food allergies, eosinophilic disorders, drug allergies, gastroenterological diseases, and more.At the Sean N. Parker Center for Allergy and Asthma Research, the world's leading scientists, physician-scientists, and research teams come together to study and understand the molecular underpinnings of allergies and asthma. We are committed to finding causes, treatments, and cures for allergies and asthma, and bringing these to children, adults, and their families at local and global levels. Transforming lives with innovative science and compassionate care.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: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.For more information about the department visit http://pathology.stanford.edu/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 assignedDesired 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.
The expected pay range for this position is $143,000 - $164,000 per annum.Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.Why Stanford is for YouImagine 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 course auditing. 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
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.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.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
Schedule: Full-time
Job Code: 4905
Employee Status: Regular
Grade: K
Requisition ID: 103407
Work Arrangement : Hybrid Eligible