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

No visa sponsorship is available. Ability to travel extensively within the USA, with occasional international travel required.

For those history buffs

i-Lumen Scientific™ is a retinal biotech company, focused on developing a medical device therapy for patients with vision loss due to intermediate to advanced dry age-related macular degeneration (AMD). We know, that’s a mouth full!

Who doesn’t want to keep their eyesight? Close your eyes for a moment or look through a pair of glasses with a dark smudge in the middle. A smudge so dark you can’t see through it. Now imagine a day when circumstances change and that’s you. Following that your doctor told you, “That’s just the way it is, and it will only get worse!”AMD is the leading cause of vision loss for older adults, has no cure, and there are limited treatments options. Our goal is to change that.

Our Mission

i-Lumen™ is working to change the status-quo by pioneering a new medical device field in ophthalmology intended to improve vision for AMD patients. This new therapy utilizes a revolutionary, non-invasive, medical device to potentially address a large unmet patient population in the practice of ophthalmology.

Are you interested in joining us on this journey? If so, we’d like to tell you a bit more about ourselves.

Our Peeps

Our team includes problem-solvers, car enthusiasts, runners, animal lovers, concert goers, and world travelers who are dedicated to improving vision for those impacted by AMD. The cool thing is, some of us have worked together in the past and we actually like each other. We are passionate about finding great people to join our team. If you are eager to invest your time, talent, and energy in our goal of making the world better one eye at a time, we encourage you to read on!

It’s not just a job

If you have been in start-ups you know hat-wearing and communication are keys to success. As we hire, expand and execute a global clinic trial, we need a cohesive team of high performers, who take accountability, know what good looks like and can bring their “A” game each and every day. We don’t do group think, but rather welcome ideas and opinions to ensure the best path forward. Have an idea? Bring it! Have a better more efficient way to get from A to Z? Suggest it! Do you ensure safety and quality of work are uncompromising? Then i-Lumen may be the place for you!

Building for a better tomorrow.

i-Lumen is seeking a Case Coverage Manager to oversee the planning, coordination, and execution of clinical treatment session coverage at clinical research sites. This role serves as a key liaison between study sites and sponsor teams, ensuring treatment sessions are appropriately supported, documented, and conducted in compliance with study protocols, Instructions for Use (IFU), Good Clinical Practice (GCP), and applicable regulatory requirements.

In addition, the Case Coverage Manager manages investigational device inventory, equipment logistics, vendor coordination, and site support activities to ensure the successful conduct of the study. The role requires strong organizational skills, attention to detail, cross-functional collaboration, and the ability to effectively manage multiple priorities in a dynamic research environment

Still interested? Let’s get into the details

Essential Functions

Case Coverage Management

• Maintain oversight of case coverage of treatment sessions and site support activities.
• Coordinate sponsor team (or outsourced designee) 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 to provide effective treatment session coverage.
• Ensure case coverage by sponsor team members (or designees) is completed in compliance with applicable SOPs, work instructions, study protocols, and quality system requirements.
• Collaborate with Clinical Operations and other cross-functional teams to support study execution and clear communication with the investigational study sites.

Case Coverage

• Attend and support treatment sessions conducted as part of clinical research studies to ensure adherence to study protocols, IFUs, and sponsor requirements.
• Provide proactive communication, confirmations, and reminders to clinical research sites regarding upcoming treatment sessions and treatment- or device-related action items.
• Complete timely and accurate Case Coverage Reports for all sessions attended.
• Identify, document, and communicate device deficiencies, protocol deviations, usability concerns, and other study-related issues to the appropriate sponsor team members.
• Support sites in addressing treatment session questions and operational challenges.
• Maintain detailed records of treatment session support activities and follow-up actions.

Device Usage Training

• Conduct and support device usage training for investigational study sites, sponsor team members, and outsourced designees per current Instructions for Use (IFU).

Device & Equipment Management

• Manage the receipt, validation, storage, inventory control, shipment, reconciliation, and accountability of investigational devices in accordance with quality procedures, study requirements, and applicable regulations.
• Coordinate the procurement, forecasting, labeling, packaging, shipment, installation, maintenance, calibration, repair, replacement, and retrieval of study-related equipment, as applicable.
• Maintain accurate inventory records, vendor documentation, and study-related equipment maintenance records to ensure accountability, traceability, and uninterrupted study operations.
• Serve as the primary point of contact for device and equipment logistics, coordinating activities with study sites, vendors, internal stakeholders, and service providers.
• Perform periodic inventory reviews and reconciliations, identify shortages or operational risks, and implement corrective actions to support study continuity.
• Ensure investigational devices and study-related equipment are available, functional, compliant, and study-ready throughout all phases of the clinical trial.

Minimum Qualifications

• Bachelor’s degree in business, Life Sciences, Biomedical Engineering, Healthcare Administration, Clinical Research, or a related field; equivalent education and experience may be considered.
• Minimum of five (5)+ years of experience in clinical research, clinical operations, medical device field clinical support, medical device operations, or a related healthcare environment.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, ISO 14155, and applicable regulations governing human subject research.
• Experience managing a team, including coordinating schedules, allocating resources, and prioritizing workload to meet operational objectives.
• Strong organizational, communication, and project coordination skills.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Experience supporting medical device clinical trials.
• Experience managing investigational device inventory and global shipments.
• Experience working with clinical research sites in multiple geographic regions.
• Proficiency in Microsoft Office applications and clinical trial management systems.
• Ability to travel domestically at approximately (50% to 60%), and as required. with occasional international travel required.