Supervising Clinical Operations 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.

Responsibilities

• Responsible for supervising and managing a team of Project Managers and Coordinators
• Serves as the guidance expert for assigned studies and is the first line of escalation
• Collaborate with the Project Director and other functional groups in the planning and administration of all phases of multi-site clinical trials
• Set and maintain priorities and timelines for project implementation, maintenance, and closeout of clinical trials across multiple national and international ATRI clinical trial study sites
• Conduct and drive study planning meetings including the management of meeting minutes, logging action items and decisions, and tracking action items to completion
• Development of various study materials including protocol, training and procedures manuals, source documents, and work instruction documents
• 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

Requirements

The ideal candidate will have excellent interpersonal skills for communicating with all levels of personnel and groups and demonstrated ability to successfully operationalize and manage all clinical trial components.

Five years of experience in clinical trials is required as well as a history of supervising staff.

Qualifications

• Five years of experience in on-site clinical trial monitoring.
• Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting.
• Demonstrated experience 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.
• Able 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.

Benefits

The annual base salary range for this position is $140,572.82 - $183,825.50. 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.