Clinical Operations Project Manager
About The Position
The USC Keck School of Medicine’s Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute that advances the development of new Alzheimer’s disease treatments through innovative clinical trials. ATRI seeks a motivated, dependable, and experienced Project Manager to support its clinical research efforts. This visible role manages the successful execution of ATRI clinical trials, serving as the primary contact and guidance expert for assigned studies and providing direction to other staff. The position requires a bachelor’s degree in biological science or a related field, or an approved combination of experience and education, and at least two years of on-site clinical trial monitoring experience. The preferred candidate has four years of experience, a relevant master’s degree, and/or clinical research certifications.
Requirements
- Bachelor’s degree in biological science or a related field; combined experience and education may substitute for the minimum education requirement.
- At least two 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 the ability to assemble, organize, and conceptualize numerical data in spreadsheets, databases, reports, and presentations.
- Lead and guidance skills, including the ability to manage and prioritize different tasks and projects.
- Interpersonal skills for communicating with staff at all levels and coordinating and executing 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.
- Four 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 within 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 other functional groups to plan and administer all phases of multi-site clinical trials.
- Set and maintain priorities and timelines for clinical-trial implementation, maintenance, and closeout across national and international study sites.
- Conduct and drive study-planning meetings; manage minutes, log action items and decisions, and track 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
