Program Manager

Company: Stanford University School of Medicine
Location: Mountain View
Posted on: May 12, 2022

Job Description:

Stanford University is seeking a Program Manager for Clinical Research (Clinical Trials Operations Manager 1) to manage the overall operational planning and activities for entire clinical trials operation for the Sean N Parker Center for Allergy and Asthma Research in compliance with GCP's, SOPs. Will supervise Clinical Research Managers and professional staff.

The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is an interdisciplinary center with focus on understanding the mechanisms of the immune system, the dysfunctions of which result 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 toward 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.

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.

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.

Keywords: Stanford University School of Medicine, Mountain View , Program Manager, Executive , Mountain View, California