Clinical Operations Senior Project Manager

University of Southern California • San Diego, CA

1d • 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 focused on advancing the development of treatments for Alzheimer’s disease through innovative clinical trials. ATRI is seeking an experienced Senior Project Manager to support its clinical research efforts. The role works independently to operationalize and manage large, multi-center clinical trial protocols.

The Senior Project Manager plans and drives assigned trials from start to finish, leads project teams, and oversees study documentation and deliverables. The position also identifies operational, monitoring, and regulatory risks; coordinates with cross-functional stakeholders; and develops templates and guidelines to support study management and improve departmental processes and efficiency.

The annual base salary range is $100,058.50–$132,725.50. USC considers factors including the position’s responsibilities, the candidate’s experience, education and skills, internal equity, applicable laws and contractual requirements, grant funding, and market and organizational considerations when making an offer. USC is an equal opportunity employer and provides reasonable accommodations to applicants and employees with disabilities.

Requirements

• Bachelor’s degree in a related field, or a combination of experience and education as a 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 and communicate with staff at all levels and with varied groups to coordinate and execute study activities.
• Excellent interpersonal and collaboration skills, clear communication, and demonstrated leadership in organizing and executing clinical trial components.

Nice To Haves

• Master’s degree in Neurosciences, Public Health, Pharmacology, or a related field, in addition to a bachelor’s degree.
• Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) certification.
• Five years of experience.
• Experience in data management.
• Excellent written and verbal communication skills, including the ability to explain 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 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 personally completed and delegated work.
• Anticipate and identify trial operational, monitoring, and regulatory risks, and ensure early intervention when needed.
• Collaborate with cross-functional stakeholders to plan, schedule, and execute deliverables and support readiness.
• Develop templates and guidelines informed by regulations, policies, and standard operating procedures for assigned studies and departmental process-improvement initiatives.

What This Job Offers

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