Clinical Operations Project Manager

University of Southern California • San Diego, CA

2d

About The Position

The Clinical Operations Project Manager collaborates with the Project Director and other functional groups to develop clinical trial scopes of work and objectives. The role assesses project feasibility, identifies priorities, enforces timelines, and ensures milestones are met. It operationalizes, implements, and manages clinical trial protocols at multiple study sites, and develops written materials to guide sites in trial execution.

The position also collaborates with functional groups to create, revise, implement, and monitor standard operating procedures and internal procedural guidelines. It serves as the point of contact and guidance expert for assigned projects and studies, and organizes and conducts training for site principal investigators and study staff.

Requirements

• Bachelor's degree in biological science or a related field, or combined experience and education as a substitute.
• At least 2 years of on-site clinical trial monitoring experience.
• 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, some familiarity with ICH-GCP guidelines, and working knowledge of FDA guidance documents.
• Technical documentation and writing skills; ability to assemble, organize, and conceptualize numerical data in spreadsheets, databases, reports, and presentations.
• Lead and guidance skills, including the ability to manage and prioritize different tasks and projects.
• Interpersonal skills to communicate with staff at all levels and coordinate and execute study activities with various individuals and groups.

Nice To Haves

• Bachelor's and master's degrees in neurosciences, public health, pharmacology, or a related field.
• Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) certification.
• 4 years of experience.
• Experience in data management.
• Excellent written and verbal communication skills for expressing 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 clinical research conduct.
• Proficiency in OmniPlan or other timeline applications.
• Familiarity with academic medical centers.

Responsibilities

• Collaborate with the Project Director and other functional groups to develop clinical trial scopes of work and objectives.
• Assess clinical project feasibility, identify priorities, enforce timelines, and ensure milestones are met.
• Operationalize, implement, and manage clinical trial protocols at multiple study sites.
• Develop written materials to guide study sites in clinical trial execution.
• Collaborate with functional groups to create, revise, implement, and monitor standard operating procedures and internal procedural guidelines.
• Serve as the point of contact and guidance expert for assigned projects and studies.
• Organize and conduct training for site principal investigators and study staff.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager