Clinical Project Manager

GE HealthCare•Waukesha, WI

About The Position

The Clinical Research Project Manager, also called a Research Program Integrator (RPI), project manages defined research activity for GE HealthCare’s Ultrasound business. The role leads cross-functional planning, tracking, status communication, and execution. It manages research projects from the strategic research management team through development, management, and closure while meeting quality, content, schedule, and budget targets. The position covers internal and external research, including GE HealthCare and investigator-sponsored studies, product evaluations, and other activities supporting strategic research needs. The RPI ensures compliance with applicable quality, clinical, regulatory, and regional requirements; coordinates research teams and external partners; develops study documentation; and maintains study records. The role partners with Research Managers and collaborates across research operations, engineering, service, quality assurance, regulatory affairs, Medical, and segment teams to deliver research activity and results on time and within budget.

Requirements

  • Bachelor’s degree in life science, engineering, a clinical field, or equivalent.
  • At least 4 years of experience project managing clinical and/or technical research studies in a clinical setting, industry, or government agency.
  • Demonstrated understanding or experience with Good Clinical Practices, global and regional research regulations, research processes, the New Product Introduction (NPI) cycle, and cross-functional interdependencies.
  • Excellent communication and interpersonal skills.
  • Demonstrated success in projects requiring accuracy with details, documentation, and communication between parties.
  • Experience working with a global and virtual team with ongoing positive outcomes and impact.
  • Must be a U.S. person (U.S. citizen, permanent resident, or other protected individual under the Immigration and Naturalization Act) because the role provides access to export-controlled technology; proof of status is required before employment.
  • Must be legally authorized to work in the United States; employment offer is conditioned on successful completion of a drug screen, as applicable.

Nice To Haves

  • Master’s degree in science or a related field, or an advanced medical degree.
  • Professional certification in project management (PMP) or clinical research (CCRP, CCRA, or CCRN).
  • Demonstrated ability to analyze and resolve problems, proactively manage projects according to timelines, and document, plan, market, and execute programs.

Responsibilities

  • Project manage defined internal and external research activities, including GE HealthCare and investigator-sponsored studies, product evaluations, and other activities supporting strategic research needs.
  • Ensure research activities comply with cross-functional standards, Phased Review Discipline, QMS, SOPs, Good Clinical Practice (GCP), and applicable regional compliance and regulatory requirements.
  • Lead cross-functional research activity teams and manage assigned research through delivery of required outputs in accordance with business needs and the study plan.
  • Partner with Research Managers on prioritization and changes to study details.
  • Develop required research documents, including protocols, plans, and informed consent forms, and manage required storage of research documents.
  • Negotiate budgets and contracts with external partners and process payments.
  • Conduct or coordinate training, study initiation, monitoring, and closure with study sites and study teams; provide quality-control review and approval support for peer studies as required.
  • Maintain applicable study records accurately and promptly, including records in Clinical Trials Management System, MyWorkshop, regional regulatory records such as ClinicalTrials.gov, Support Central, and other study records.
  • Build relationships with external research partners and manage communication with external sites professionally and productively.
  • Collaborate with Research Managers, regional Research Managers, research operations, engineering, service, quality assurance, regulatory affairs, Medical, and segment team members to deliver research activity and results on time, within budget, and with required deliverables.

Benefits

  • Professional development
  • Competitive compensation
  • Relocation assistance is not provided.
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