Clinical Monitoring Line Manager

The USC Keck School of Medicine Alzheimers 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 Alzheimers Disease (AD) through innovative clinical trials.

The Medical & Safety team within ATRI is seeking an experienced Clinical Monitoring Line Manager with strong supervisory skills and a background within clinical trials. Duties will include but are not limited to:

• Supervise mentor and train Clinical Monitors for sponsor and investigator initiated clinical research
• Oversee study site assignments monitoring deliverables and team performance
• Ensure compliance with institutional guidelines ICH GCP FDA CFR HIPAA Health Canada Division 5 and other country equivalents
• Collaborate with team of managers and Lead Clinical Monitors on process improvement and staff development initiatives
• Support study team with study conduct regulatory inspections audits and coordinating center responsibilities
• In conjunction with Lead Clinical Monitor oversee assigned clinical studies ensuring that monitoring deliverables are met collaborate with pharmaceutical and vendor partners join/host study specific meetings and contribute to other study specific initiatives
• Recruit screen interview hire and supervise clinical monitor team members
• Responsible for clinical monitor training and ongoing clinical trial education for clinical monitor team
• Responsible for conducting performance evaluations setting goals and providing counsel when appropriate
• Travel to study clinical sites for onsite monitoring and monitor evaluation visits
• Collect and analyze delivery productivity and performance metrics of Clinical Monitors

Job requirements

• Experience in clinical trials and team leadership
• In-depth knowledge of ICH Good Clinical Practice (GCP) FDA CFR and HIPAA guidelines
• Excellent training mentoring and communication skills
• Ability to analyze monitoring metrics and implement improvements
• Ability to work as part of a management team and contribute to process development and improvements
• Ability to travel up to 25%

Location: San Diego CA

The salary range for this position is $131588.25 - $169704.98. 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 candidates 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.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at or by email at. Inquiries will be treated as confidential to the extent permitted by law.

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Manager