Clinical Operations Senior Project Manager

About the role

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators, committed to advancing the development of new treatments for Alzheimer's Disease (AD) through innovative clinical trials.

The ATRI is seeking a motivated, dependable, and experienced Senior Project Manager to support ATRI clinical research efforts. The Senior Project Manager works independently to operationalize and manage large multi-center clinical trial protocols. Responsibilities include, but are not limited to:

• Strategize, plan, and drive the execution of all aspect of assigned clinical trial protocols while ensuring alignment with project scope
• Lead project teams, provide work direction, and delegates tasks to other staff personnel
• Oversees the development and implementation of documentation for each study, including protocols, training and procedures manuals, source documents, work instruction documents, project plans, timelines, and reports
• Assurnace of accuracy and quality for work that is delegated and completed personally
• Proactively anticipates and indentifies trial operational, monitoring, and regulatory risks, ensuring early intervention when needed
• Collabroates with numerous cross-fucntional stakeholders to drive readiness through planning, scheduling, and execution of all deliverables
• Development of templates and guidelines, informed by regulations, policies, and standard operating procedures (SOPs) for the management of assigned studies, as well as departmental initiatives aimed at improving process and efficiency

The ideal candidate will have excellent interpersonal skills for collaboration with all levels of personnel and groups, clear and articulate communications, and demonstrated leadership skills for executing and organizing all clinical trial components.

Five to three years of experience in multi-center clinical trials management is required.

Location: San Diego, CA

The annual base salary range for this position is $100,058.50 - $132,725.50. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education

• Bachelor's degree in related field(s)
• Addtional Education Requirements Combined experience/education as substitute for minimum education

Minimum Experience

3 years in on-site clinical trial monitoring.

• Minimum Skills: 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.

Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Ability to manage and prioritize different tasks and projects, with deft interpersonal skills for communicating with all levels of staff and various individuals and groups coordinating and executing study activities.

Preferred Education

Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s)

Preferred Certifications

Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).

Preferred Skills

• Experience in data management.
• Excellent written and verbal communication skills to express 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 the clinical research conduct.
• Proficient in OmniPlan or other timeline applications.
• Familiarity with academic medical centers.

• Notice of Non-discrimination
• Employment Equity
• Read USC's Clery Act Annual Security Report
• USC is a smoke-free environment
• Digital Accessibility

Additional information

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