Clinical Monitoring Director

University of Southern California•San Diego, CA

8d•$122,817 - $170,101•Onsite

About The Position

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. Incumbent will assist the Medical Director with providing oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operation Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements(s). Duties will include but are not limited to: Directs the Clinical Monitor Managers who supervise the clinical monitoring team for sponsor and investigator-initiated clinical research Responsible for providing leadership to the Clinical Monitoring team including developing and advancing processes for monitor metrics reviews, site assignments, daily operations, and data query placements, and closures Ensures site qualifications, initiations, monitoring, and study closeout visits are conducted in accordance with relevant regulatory regulations. Responsible for managing ongoing documentation, regulatory, and policy changes and updates for clinical monitoring procedures Serves as primary communications liaison for clinical monitoring team with other ATRI units, study teams and sponsors Responsible for ensuring Clinical Monitor Managers develop and administer continuous clinical trial education, creating instructional and coaching plans to appropriate staff qualifications and training Provides oversight of Clinical Monitor Managers in their recruitment, screening, interviewing, hiring, and supervision of clinical monitors Provides guidance to Clinical Monitor Manager processes surrounding clinical monitor training and ongoing clinical trial education for monitors Responsible for conducting performance evaluations, setting goals, and providing counsel when appropriate of Clinical Monitor Managers and Clinical Monitors when needed Accountable for oversight of collecting and analyzing delivery, productivity, and performance metrics of Clinical Monitors and Clinical Monitor Managers

Requirements

At minimum bachelor’s degree or equivalent in medical-related field or life science.
An understanding of Alzheimer’s disease and/or the drug development process
Experience in interacting with cross functional study team members
Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
Read, write, and speak fluent English, excellent verbal, and written communications skills

Nice To Haves

Post-graduate (medical) degree preferred.

Responsibilities

Directs the Clinical Monitor Managers who supervise the clinical monitoring team for sponsor and investigator-initiated clinical research
Responsible for providing leadership to the Clinical Monitoring team including developing and advancing processes for monitor metrics reviews, site assignments, daily operations, and data query placements, and closures
Ensures site qualifications, initiations, monitoring, and study closeout visits are conducted in accordance with relevant regulatory regulations.
Responsible for managing ongoing documentation, regulatory, and policy changes and updates for clinical monitoring procedures
Serves as primary communications liaison for clinical monitoring team with other ATRI units, study teams and sponsors
Responsible for ensuring Clinical Monitor Managers develop and administer continuous clinical trial education, creating instructional and coaching plans to appropriate staff qualifications and training
Provides oversight of Clinical Monitor Managers in their recruitment, screening, interviewing, hiring, and supervision of clinical monitors
Provides guidance to Clinical Monitor Manager processes surrounding clinical monitor training and ongoing clinical trial education for monitors
Responsible for conducting performance evaluations, setting goals, and providing counsel when appropriate of Clinical Monitor Managers and Clinical Monitors when needed
Accountable for oversight of collecting and analyzing delivery, productivity, and performance metrics of Clinical Monitors and Clinical Monitor Managers
Manages clinical research program operations, services, day-to-day activities and administrative functions.
Participates in the development of short- and long-term program strategies.
Manages team members, and is responsible for staff and team development.