Clinical Operations Senior Project Manager
About The Position
The USC Keck School of Medicine’s Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute focused on advancing new treatments for Alzheimer’s disease through innovative clinical trials. ATRI seeks an experienced Senior Project Manager to independently operationalize and manage large, multi-center clinical trial protocols. The role requires collaboration with cross-functional stakeholders and leadership in planning and executing trial activities and deliverables. The ideal candidate has strong interpersonal, communication, and leadership skills, and can organize and execute all components of clinical trials. The position requires a bachelor’s degree in a related field, or qualifying combined experience and education, and at least three years of on-site clinical trial monitoring. Preferred qualifications include a bachelor’s and master’s degree in neuroscience, public health, pharmacology, or a related field; five years of experience; and CCRA and/or CCRC certification. The annual base salary range is $100,058.50–$132,725.50. USC considers factors including the position’s scope and responsibilities, candidate experience and education, skills, internal equity, applicable laws, funding, and market and organizational considerations when making offers.
Requirements
- Bachelor’s degree in a related field; combined experience and education may substitute for the minimum education requirement.
- At least three years of experience in on-site clinical trial monitoring.
- 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.
- Skill in technical documentation and writing, and in assembling, organizing, and conceptualizing numerical data in spreadsheets, databases, reports, and presentations.
- Ability to manage and prioritize different tasks and projects.
- Interpersonal skills to communicate with all levels of staff and coordinate and execute study activities with individuals and groups.
- Clear and articulate communication, collaboration, and leadership skills.
Nice To Haves
- Bachelor’s and master’s degrees in neuroscience, public health, pharmacology, or a related field.
- Five years of experience.
- Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) certification.
- Experience in data management.
- Excellent written and verbal communication skills for conveying complex ideas to study staff at research and clinical institutions.
- Ability to handle several priorities across multiple complex clinical trials.
- Strong understanding of current GCP guidelines applicable to clinical research conduct.
- Proficiency in OmniPlan or other timeline applications.
- Familiarity with academic medical centers.
Responsibilities
- Strategize, plan, and drive execution of all aspects of assigned clinical trial protocols while ensuring alignment with project scope.
- Lead project teams, provide work direction, and delegate tasks to staff.
- Oversee development and implementation of study documentation, including protocols, training and procedures manuals, source documents, work instructions, project plans, timelines, and reports.
- Ensure the accuracy and quality of personally completed and delegated work.
- Anticipate and identify trial operational, monitoring, and regulatory risks, and ensure early intervention when needed.
- Collaborate with cross-functional stakeholders to drive readiness through planning, scheduling, and execution of deliverables.
- Develop templates and guidelines informed by regulations, policies, and standard operating procedures (SOPs) for assigned studies and departmental initiatives to improve processes and efficiency.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
