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 that advances the development of new treatments for Alzheimer’s disease through innovative clinical trials. ATRI seeks a motivated, dependable, and experienced Senior Project Manager to support its clinical research efforts. The role works independently to operationalize and manage large, multicenter clinical trial protocols. The position leads the planning and execution of assigned clinical trial protocols, provides work direction to project teams, and oversees study documentation and deliverables. It also supports quality assurance, risk identification and intervention, cross-functional coordination, and the development of templates and guidelines informed by regulations, policies, and standard operating procedures. The ideal candidate has strong interpersonal, communication, and leadership skills for organizing and executing clinical trial components.
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, 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.
- Skill in technical documentation and writing, and in assembling, organizing, and conceptualizing numerical data in spreadsheets, databases, reports, and presentations.
- Ability to manage and prioritize different tasks and projects, with interpersonal skills to communicate with staff at all levels and coordinate and execute study activities.
- Excellent interpersonal, communication, and leadership skills for collaboration and organizing clinical trial components.
Nice To Haves
- Preferred education: 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.
- 5 years of experience.
- Experience in data management.
- Excellent written and verbal communication skills, including the ability to express 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
- 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 work completed personally.
- Anticipate and identify trial operational, monitoring, and regulatory risks, and ensure 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 initiatives to improve processes and efficiency.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
