Device Accountability Specialist

Position Summary

This position is responsible for the oversight and management of investigational inventory on clinical studies. A Device Accountability Specialist is responsible for communicating clinical orders, returns, and invoices to Customer Service teams and managing inventory levels at study sites to ensure product is available for study enrollments.

In addition, this role is responsible for site aging inventory, product reconciliation, and audit readiness, working independently with minimal guidance while ensuring compliance with study protocols, domestic and international Good Clinical Practices (GCP), applicable regulatory standards, and client Standard Operating Procedures. The role requires the ability to solve complex problems and consider alternative or new perspectives using existing tools and standard processes.

Essential Functions

1. Places order and return requests with Customer Service for clinical study sites worldwide.
2. As applicable, assists in the collection of billable purchase order numbers for clinical product and submits billable invoices to Customer Service worldwide.
3. Manages aging product shelf life at clinical study sites and proactively communicates with the Project Management team to minimize scrap.
4. Manages device inventory levels at sites throughout the course of the clinical study in alignment with the Project Manager.
5. Serves as a liaison to both in-house study teams and field clinical personnel regarding inventory transactions, usage, and storage.
6. Assists in the setup of appropriate investigational inventory in SAP systems and Clinical Inventory Management systems.
7. Communicates with Customer Service, Regulatory Operations, and Distribution Centers, including situations requiring complex problem solving as needed.
8. Provides training as needed to cross-functional client teams regarding inventory management systems and processes.
9. Authors and maintains clinical study inventory management plans.
10. Completes audit readiness activities and product reconciliation for inventory on clinical studies.
11. Provides clinical study teams with data regarding device usage for regulatory reporting.
12. Serves as a liaison to Customer Service and study management personnel for any inventory-related issues; escalates as appropriate.
13. Processes Product Release Authorizations in client Quality Systems per applicable SOPs and Work Instructions.

Other Duties

1. Develops an understanding of current clinical regulations and common industry practices related to inventory management and seeks continuing education about client devices and therapies.
2. Manages projects and process improvement efforts that support departmental goals and objectives concerning inventory management.
3. Attends and leads both individual study team and cross-functional program management group meetings.
4. Some travel may be required (~5%).
5. May support tasks outside normal business hours (e.g., urgent access to restricted devices, meetings with teams outside U.S. time zones).

Qualifications

Required:

• Bachelor’s degree from an accredited university or college (preferably in natural science, pre-medicine, nursing, bioengineering, or related field) OR at least five years of clinical research experience.
• Minimum of two years of clinical research or medical device experience.
• Strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills.
• Ability to interpret clinical data, meet deadlines, and work effectively with all levels of employees.
• Proficiency in Microsoft Office Suite and relevant clinical applications.
• Ability to work independently and troubleshoot complex problems.
• Ability to exchange straightforward information, ask questions, and confirm understanding.

Preferred:

• Experience with SAP, Customer Service, supply/demand planning, device transactions, and pre-market studies.
• Understanding of clinical research, specifically medical device or pharmaceutical trials.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies.
• Previous research experience in a clinical or corporate setting or relevant clinical/hospital experience.
• Strong organizational skills, attention to detail, and ability to coordinate multiple tasks.

Term & Start

• Contract through the end of the year, potential to extend
• Start July 1
• On-site 4 days/week in Maple Grove, MN, 1 day/week remote
• Medical, Dental, & Vision Benefits available