Clinical Trials Operations Manager 1

🔍 School of Medicine, Stanford, California, United States

New

📁: Research

📅   : 1 day ago Post Date

📅   : 108909 Requisition #

Director, Immune Behavioral Health Clinical Research Network Coordinating Center (CRNCC)

Stanford University is seeking a Director to establish and lead the Immune Behavioral Health Clinical Research Network Coordinating Center (CRNCC) within the Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, as part of the Immune Behavioral Health (IBH) Research Program.

The IBH-CRNCC will focus on autoimmune and immune-mediated psychiatric conditions, including Pediatric Acute-onset Neuropsychiatric Syndrome (PANS), autism spectrum conditions with immune involvement, and related disorders. The program’s mission is to build the scientific and operational infrastructure required to enable high-quality, multi-site clinical trials in this emerging field.

The incumbent will lead the development of a clinical research network and oversee end-to-end clinical trial design and execution. This includes protocol development, feasibility assessment, site identification and activation, and establishment of standardized tools and processes to support scalable, multi-site research.

Core responsibilities center on clinical trial design and methodology, including defining study objectives, selecting study designs, developing and selecting outcome measures, determining inclusion/exclusion criteria, conducting sample size and power calculations, designing consent processes, and developing data collection and management strategies.

The incumbent will oversee the full clinical trial lifecycle, including study start-up, regulatory approvals, safety oversight, study conduct, close-out, and data analysis. The individual will ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements across all participating sites.

The Director will build and lead a multidisciplinary team and supervise junior staff and trainees. The role also includes contributing to dissemination of findings through manuscripts, presentations, and grant-supported research.

This position offers a unique opportunity to build a clinical research ecosystem at the intersection of immunology and psychiatry, enabling coordinated, data-driven approaches to disease characterization and treatment development. Learn more about the Program’s research https://med.stanford.edu/pans/publications.html and direct questions to Frankovich_admin@stanford.edu

* - Other duties may also be assigned

The position is based in Palo Alto but a Hybrid or remote work agreement may be considered

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. The salary for this position working in the California Bay area is between $159,521 to $177,998 based on commensurate experience and background.

DESIRED QUALIFICATIONS:

Advanced degree (e.g., PhD, MD, or equivalent) with 10+ years of experience in clinical research, project management, and/or scientific investigation

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience. Extensive experience in clinical research and or clinical trials.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

· Demonstrated experience leading and managing clinical trial staff.

· Demonstrated experience leading multi-site or large-scale clinical trials research.

· Demonstrated expertise in clinical trial design and methodology

· Experience with statistical concepts including sample size estimation and study design

· 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.

· Strong scientific writing abilities and record of scientific publications.

· Experience developing and submitting grant proposals.

· Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.

· Excellent written, verbal, interpersonal, and presentation skills.

· Experience or interest in neuroimmunology, autoimmune disease, psychiatry, or related translational research areas is strongly preferred

CERTIFICATIONS & LICENSES:

None.

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:

· May require extended or unusual work hours based on research requirements and business needs.

Infrequent travel may be required for conferences, scientific meetings, etc

Additional Information