Clinical Operations Project Manager San Diego, California

Company: University of Southern California
Location: San Diego
Posted on: March 4, 2025

Job Description:

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators, committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials.The ATRI is seeking a motivated, dependable, and experienced Project Manager to support ATRI clinical research efforts. The Project Manager is a highly visible role responsible for managing the successful execution of ATRI clinical trials. Responsibilities include, but are not limited to:

• Collaborate with the Project Director and other functional groups in the planning and administration of all phases of multi-site clinical trials.
• Set and maintain priorities and timelines for project implementation, maintenance, and closeout of clinical trials across multiple national and international ATRI clinical trial study sites.
• Conduct and drive study planning meetings including the management of meeting minutes, logging action items and decisions, and tracking action items to completion.
• Serve as the primary point of contact and guidance expert for assigned studies.
• Provide work direction and delegate tasks to other staff personnel.
• Develop various study materials including protocol, training and procedures manuals, source documents, and work instruction documents.
• Develop templates and guidelines, informed by regulations, policies, and standard operating procedures (SOPs) for the management of assigned studies, as well as departmental initiatives aimed at improving process and efficiency.The ideal candidate will have excellent interpersonal skills for communicating with all levels of personnel and groups and demonstrated ability to successfully operationalize and manage all clinical trial components.Minimum Education: Bachelor's degree in Biological Science or in related field(s).Minimum Experience: 2 years in on-site clinical trial monitoring.Minimum Skills: Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting. Demonstrated experience using medical devices and terminology. Experience applying policies and procedures, with some familiarity with ICH-GCP guidelines and working knowledge of FDA guidance documents. Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Lead/guidance skills, with the ability to manage and prioritize different tasks and projects. Deft interpersonal skills for communicating with all levels of staff and diverse individuals and groups coordinating and executing study activities.Preferred Education: Bachelor's degree and Master's degree in Neurosciences or Public Health or Pharmacology or in related field(s).Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).Preferred Experience: 4 years.Preferred Skills: Experience in data management. Excellent written and verbal communication skills to express complex ideas to study staff at research and clinical institutions. Ability to handle several priorities within multiple, complex clinical trials. Strong understanding of current GCP guidelines applicable to the clinical research conduct. Proficient in OmniPlan or other timeline applications. Familiarity with academic medical centers.
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