Supervising Clinical Operations Project Manager

University of Southern CaliforniaSan Diego, CA
$140,573 - $183,826Onsite

About The Position

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 Supervising - Project Manager to support ATRI clinical research efforts. This is a highly visible role, responsible for managing the successful execution of ATRI clinical trials.

Requirements

  • Five years of experience in clinical trials is required
  • history of supervising staff
  • Industry experience in a pharmaceutical, biotechnology, clinical research organization and/or nursing setting.
  • Demonstrated experience 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.

Nice To Haves

  • 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.

Responsibilities

  • Responsible for supervising and managing a team of Project Managers and Coordinators
  • Serves as the guidance expert for assigned studies and is the first line of escalation
  • 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
  • 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

Benefits

  • excellent benefits and perks
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