Clinical Project Manager

GE HealthCare (United States); Waukesha (WI); On-site; USD 95,000 - 140,000; Full time

Job summary

GE HealthCare is seeking a Clinical Research Project Manager (RPI) to lead cross-functional planning and execution of ultrasound research activity across regions.

You will manage end-to-end delivery of studies from planning through closure, ensuring quality, schedule and budget targets, while collaborating with internal partners and external sites.

Qualifications

• Bachelor’s degree in life sciences, engineering, clinical field, or equivalent.
• 4+ years of experience managing clinical and/or technical research studies.
• Familiarity with Good Clinical Practices, global/regional regulations, NPI cycle and cross-functional interdependencies.
• Excellent communication and interpersonal skills.
• Experience working with global and virtual teams.

Responsibilities

• Project manages defined research activity including internal/external studies, product evaluations, and investigator-initiated studies.
• Ensures compliance with QMS, SOPs, GCP and regulatory requirements across regions.
• Leads cross-functional team to deliver research deliverables per study plan within scope and budget.
• Partners with Research Manager for prioritization and changes to study details.
• Develops protocols, plans, informed consent forms, and manages storage of study documents.
• Negotiates budgets and contracts with external partners and processes payments.
• Coordinates required training, initiation, monitoring and closure with study sites; provides QC support.
• Maintains study records in systems and regulatory files.
• Develops relationships with external partners and manages communications with sites.
• Works with regional and cross-functional teams to deliver research activity and results on time, within budget.

Skills

Excellent communication

Interpersonal skills

Project coordination

Cross-functional collaboration

Education

Bachelor’s Degree in life science, engineering, clinical field or equivalent

Master’s Degree in science or related field

Job description

Job Description Summary

The Clinical Research Project Manager (Research Program Integrator- RPI) is responsible for project managing defined research activity for Ultrasound business(es) within GE Healthcare. The RPI leads cross-functional planning, tracking, communication of status, and execution of research activity. The RPI manages wing to wing execution for research activity taking defined projects from the strategic research management team through development, management, and closure, while meeting all quality, content, schedule, and budget targets.

Job Description Summary

The Clinical Research Project Manager (Research Program Integrator- RPI) is responsible for project managing defined research activity for Ultrasound business(es) within GE Healthcare. The RPI leads cross-functional planning, tracking, communication of status, and execution of research activity. The RPI manages wing to wing execution for research activity taking defined projects from the strategic research management team through development, management, and closure, while meeting all quality, content, schedule, and budget targets.

Job Description

Roles and Responsibilities

• Project manages defined research activity, which includes, internal and external, GE HealthCare and Investigator Sponsored studies, product evaluations, and other activities defined to meet strategic research needs.
• Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions.
• Leads the cross-functional research activity team and project manages the activity to conduct assigned internal and external research activity and deliver the required deliverables per the business needs and defined study plan.
• Partners with the Research Manager (RM) for prioritization and changes to study details.
• Develops research documents as required, including protocols, plans, informed consent forms, and required storage of research documents including managing.
• Negotiates budget and contracts with external partners and processes payments.
• Conducts and/or coordinates required training, initiation, monitoring and closure with study site and study team. Serves as QC to support review and approval of these activities for peer studies as required.
• Maintains applicable study records in a timely and accurate fashion which may include Clinical Trials Management System, MyWorkshop, regional regulatory records (e.g. ClinicalTrials.gov), Support Central, and/or other study records.
• Develops relationships with and supports external research partners and manages communication with external sites in a professional and productive manner.
• Works with RMs, regional RMs, research operations, engineering teams, service, QA, RA, Medical, and segment team members to conduct and deliver research activity and results on time, within budget and with the necessary deliverables.

Required Qualifications

• Bachelor’s Degree in life science, engineering, clinical field or equivalent
• 4+ years of experience project managing clinical and/or technical research studies in a clinical setting, industry, or government agency
• Demonstrated understanding/experience with Good Clinical Practices, global and regional research regulations, research processes, 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 in working with a global and virtual team with ongoing positive outcomes and impact

Desired Characteristics

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

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)) due to access to export-controlled technology. GE HealthCare will require proof of status prior to employment.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No