Clinical Operations Project Manager

University of Southern California; San Diego (CA); On-site; USD 89,000 - 118,000; Full time

Job summary

The University of Southern California Keck School of Medicine ATRI in San Diego, CA is seeking a Project Manager to oversee ATRI clinical trials. This highly visible role partners with the Project Director and cross-functional teams to drive study execution across multiple sites.

Responsibilities include planning meetings, maintaining timelines, developing protocol and training materials, and guiding assigned studies.

Qualifications

• Bachelor's degree in Biological Science or related field.
• Minimum 2 years of on-site clinical trial monitoring experience.
• Industry experience in pharmaceutical/biotech/CRO or nursing settings.
• Experience with medical devices and terminology.
• Familiarity with ICH-GCP guidelines and FDA guidance documents.
• Proficient in technical documentation and data presentation.
• Ability to lead and prioritize multiple tasks.
• Strong interpersonal and communication skills.
• Familiarity with academic medical centers.

Responsibilities

• Collaborate with the Project Director and other groups in planning and administering multi-site trials.
• Set and maintain priorities and timelines for trial implementation across sites.
• Conduct and drive study planning meetings and track action items to completion.
• Serve as primary contact and guidance expert for assigned studies.
• Provide work direction and delegate tasks to staff.
• Develop study materials including protocol, training manuals, source documents, and work instructions.
• Create templates and guidelines based on SOPs and regulations to improve processes.

Skills

Interpersonal skills

Leadership

Documentation

Clinical monitoring

Regulatory knowledge

GCP knowledge

Spreadsheets/databases

Timeline tools

Academic medical centers

Communication skills

Education

Bachelor's in Biological Science or related field

Master's degree in Neuroscience/Public Health/Pharmacology or related field

Tools

OmniPlan

Job description

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 Project Manager to support ATRI clinical research efforts. The Project Manager is a highly visible role responsible for managing the successful execution of ATRI clinical trials. Responsibilities include, but are not limited to:

• 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
• Serves as the primary point of contact and guidance expert for assigned studies
• Provides work direction and delegates tasks to other staff personnel
• 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

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.

Two to three years of experience in clinical trials is required.

Location: San Diego, CA

The annual base salary range for this position is $88,721.66 - $118,129.88. 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 Biological Science Or in related field(s)

Addtional Education Requirements:

Combined experience/education as substitute for minimum education

Minimum Experience:

2 years in on-site clinical trial monitoring.

Minimum Skills:

Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting

Demonstrated experience using medical devices and terminology.

Experience applying policies and procedures, with some familiarity with ICH-GCP guidelines and working knowledge of FDA guidance documents.

Skilled at technical documentation and writing, and at assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations.

Lead/guidance skills, with the ability to manage and prioritize different tasks and projects.

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:

4 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.