Clinical Operations Senior Project Manager

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
• Assurance 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.

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.  

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 Experience: 5 years
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.

                                                  

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 the Background Screening Policy Appendix D for 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 (213) 821-8100, or by email at [email protected]. Inquiries will be treated as confidential to the extent permitted by law.

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