Research Program Manager: Clinical Trials & Compliance

HC1316 GE Precision Healthcare LLC; Waukesha (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

GE HealthCare in the United States seeks a Research Program Integrator to manage research activities for OB AI products and obtain FDA clearance. You will lead cross-functional planning, track progress, communicate status, and drive execution across the full lifecycle from strategy to closure, ensuring quality, schedule and budget targets are met.

Responsibilities include overseeing research activities, coordinating with external partners, ensuring IRB and GCP compliance, developing protocols

Qualifications

• Bachelor’s degree in life sciences, engineering, clinical field, or equivalent.
• 5+ years of experience in clinical or technical research programs in a clinical setting, industry.
• Experience managing research projects in a medical device or pharmaceutical company.
• Patient-facing experience and experience with sponsored studies.
• Strong understanding of Good Clinical Practices (GCP) and global/regional regulations.

Responsibilities

• Oversee defined research activities to meet strategic research needs.
• Coordinate regularly among external collaborators and internal stakeholders.
• Ensure research activities comply with study protocols, IRB policy, GCP and regulatory requirements.
• Lead cross-functional research teams to conduct internal and external activities.
• Develop necessary research documents, including protocols, plans, consent forms and source documents.
• Maintain investigator site file documentation and regulatory binders.
• Negotiate budgets and contracts with external partners and process payments.
• Complete IRB submissions such as new study submissions and continuing reviews.
• Train study staff and prepare for audits.
• Maintain study records in CTMS, MyWorkshop, and regional regulatory records.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge (GCP/IRB)

Documentation & records management

Budget & contracts negotiation

Education

Bachelor’s degree in life sciences, engineering, clinical field, or equivalent

Tools

Clinical Trials Management System

MyWorkshop

Job description

GE HealthCare in the United States seeks a Research Program Integrator to manage research activities for OB AI products and obtain FDA clearance. You will lead cross-functional planning, track progress, communicate status, and drive execution across the full lifecycle from strategy to closure, ensuring quality, schedule and budget targets are met.

Responsibilities include overseeing research activities, coordinating with external partners, ensuring IRB and GCP compliance, developing protocols