Global Clinical Case Coverage Manager

i-Lumen Scientific, Inc.; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

i-Lumen Scientific, Inc. is seeking a Case Coverage Manager to oversee planning, coordination, and execution of clinical treatment session coverage at clinical research sites.

You will serve as a liaison between study sites and sponsor teams to ensure sessions are supported, documented, and conducted per IFU, GCP, ISO 14155, and regulations. You will also manage investigational device inventory, equipment logistics, vendor coordination, and site support to ensure successful study conduct.

Qualifications

• Bachelor’s degree required in a relevant field.
• Minimum of five (5)+ years in clinical research or related healthcare environment.
• Knowledge of GCP, ICH guidelines, ISO 14155, and applicable regulations.
• Experience managing a team and coordinating schedules/resources.
• Strong organizational, communication, and project coordination skills.
• Willingness to travel domestically up to 60%.

Responsibilities

• Maintain oversight of case coverage of treatment sessions and site support activities.
• Coordinate sponsor team attendance and resource allocation for study-related treatment sessions.
• Develop and maintain coverage schedules to ensure adequate support across study sites.
• Train and onboard team members on device usage, case coverage process, and work instructions.
• Ensure case coverage in compliance with SOPs, study protocols, and quality system requirements.
• Collaborate with Clinical Operations and cross-functional teams to support study execution and clear communication with study sites.
• Attend and support treatment sessions to ensure adherence to study protocols and sponsor requirements.
• Complete timely Case Coverage Reports for all sessions attended.
• Identify and communicate device deficiencies, protocol deviations and usability concerns.

Skills

GCP/ICH/ISO 14155 knowledge

Team leadership

Organizational skills

Project coordination

Microsoft Office proficiency

CTMS knowledge

Travel readiness

Education

Bachelor’s degree in Business, Life Sciences, Biomedical Engineering, Healthcare Administration, Clinical Research, or related field

Tools

Microsoft Office

Clinical Trial Management Systems

Job description

i-Lumen Scientific, Inc. is seeking a Case Coverage Manager to oversee planning, coordination, and execution of clinical treatment session coverage at clinical research sites.

You will serve as a liaison between study sites and sponsor teams to ensure sessions are supported, documented, and conducted per IFU, GCP, ISO 14155, and regulations. You will also manage investigational device inventory, equipment logistics, vendor coordination, and site support to ensure successful study conduct.