Clinical Operations Senior 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 focused on advancing the development of treatments for Alzheimer’s disease through innovative clinical trials. ATRI is seeking an experienced Senior Project Manager to independently operationalize and manage large, multicenter clinical trial protocols. The role leads the planning and execution of assigned trials, coordinates project teams and cross-functional stakeholders, and oversees study documentation and deliverables. The Senior Project Manager also identifies operational, monitoring, and regulatory risks, supports early intervention, and develops templates and guidelines to improve study management, processes, and efficiency. The position requires strong communication, collaboration, organization, and leadership skills.
Requirements
- Bachelor’s degree in a related field; combined experience and education may substitute for the minimum education requirement.
- At least 3 years of experience in on-site clinical trial monitoring.
- Industry experience in a pharmaceutical, biotechnology, clinical research organization, and/or nursing setting.
- Demonstrated experience managing and supervising others.
- Experience using medical devices and terminology and managing study records, finances, and vendors.
- Theoretical understanding of health sciences research and ICH-GCP guidelines, with experience applying policies and procedures.
- Technical documentation and writing skills.
- Ability to assemble, organize, and conceptualize numerical data in spreadsheets, databases, reports, and presentations.
- 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
- Preferred education: bachelor’s degree and master’s degree in neuroscience, public health, pharmacology, or a related field.
- Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
- Five years of experience.
- Experience in data management.
- Excellent written and verbal communication skills, including explaining complex ideas to study staff at research and clinical institutions.
- Ability to manage 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
- Strategize, plan, and drive execution of all aspects of assigned clinical trial protocols in alignment with project scope.
- Lead project teams, provide work direction, and delegate tasks to staff.
- Oversee development and implementation of study documentation, including protocols, training and procedures manuals, source documents, work instructions, project plans, timelines, and reports.
- Ensure the accuracy and quality of delegated work and personally completed work.
- Anticipate and identify trial operational, monitoring, and regulatory risks, ensuring early intervention when needed.
- Collaborate with cross-functional stakeholders to drive readiness through planning, scheduling, and execution of deliverables.
- Develop templates and guidelines informed by regulations, policies, and standard operating procedures for assigned studies and departmental process-improvement initiatives.
Benefits
- Reasonable accommodations are available to applicants and employees with disabilities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
