Clinical Operations Project Manager

University of Southern California • San Diego, CA

14h • $88,722 - $118,130 • Onsite

About The Position

The USC Keck School of Medicine’s Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute of scientific collaborators advancing treatments for Alzheimer’s disease through clinical trials. ATRI is seeking an experienced Project Manager to manage the successful execution of its clinical trials. The role supports multi-site studies at national and international sites and coordinates planning, implementation, maintenance, and closeout. The Project Manager serves as the primary contact and guidance expert for assigned studies, works with the Project Director and functional groups, and provides direction to other staff. The position also develops study materials and guidance documents and contributes to departmental process and efficiency improvements.

Requirements

• Bachelor’s degree in biological science or a related field; combined experience and education may substitute for the minimum education requirement.
• At least 2 years of experience in on-site clinical trial monitoring.
• 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, some familiarity with ICH-GCP guidelines, and working knowledge of FDA guidance documents.
• Technical documentation and writing skills, including assembling, organizing, and conceptualizing numerical data in spreadsheets, databases, reports, and presentations.
• Lead and guidance skills, with the ability to manage and prioritize different tasks and projects.
• Interpersonal skills to communicate with staff at all levels and coordinate and execute study activities.

Nice To Haves

• Bachelor’s and master’s degrees in neurosciences, public health, pharmacology, or a related field.
• Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) certification.
• 4 years of experience.
• Experience in data management.
• Excellent written and verbal communication skills for expressing complex ideas to study staff at research and clinical institutions.
• Ability to handle several priorities across multiple, complex clinical trials.
• Strong understanding of current GCP guidelines applicable to clinical research conduct.
• Proficiency in OmniPlan or other timeline applications.
• Familiarity with academic medical centers.

Responsibilities

• Collaborate with the Project Director and functional groups to plan and administer all phases of multi-site clinical trials.
• Set and maintain priorities and timelines for implementation, maintenance, and closeout of clinical trials across national and international study sites.
• Conduct and drive study planning meetings; manage meeting minutes, log action items and decisions, and track action items through 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 study materials, including protocols, training and procedures manuals, source documents, and work instruction documents.
• Develop templates and guidelines informed by regulations, policies, and standard operating procedures for assigned studies and departmental process-improvement initiatives.
• Operationalize and manage clinical trial components.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level