Clinical Systems Coordinator

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!  

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. 

 Why you’ll love working at Axogen: 

• Friendly, open, and fun team culture that values unique perspectives 
• Company-wide dedication to profoundly impacting patients’ lives 
• Comprehensive, high-quality benefits package effective on date of hire 
• Educational assistance available for all employees 
• Matching 401(k) retirement plan 
• Paid holidays, including floating holidays, to be used at your discretion 
• Employee Stock Purchase Plan 
• Referral incentive program 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Clinical Systems Coordinator

The Clinical Systems Coordinator is responsible for administering Axogen’s clinical systems, including Veeva Vault, performing quality control of clinical trial documents, and supporting study start-up and coordination activities. This role ensures compliance with regulatory standards, supports in-house and remote monitoring initiatives, and facilitates efficient clinical operations through system and process management. Additionally, the Clinical Systems Coordinator contributes to the development, growth, and maintenance of Clinical Research Systems and Infrastructure to ensure scalability and operational excellence. This role requires close collaboration with internal and external stakeholders to streamline processes, enhances system capabilities, and support Axogen’s clinical trial objectives.

Requirements of the Clinical Systems Coordinator

• Bachelor’s degree in a medical, scientific, engineering, or computer systems discipline or a commensurate combination of training and experience;
• Prior experience with industry-sponsored clinical research is strongly preferred.
• 1-2 years of prior experience working with Veeva Clinical Suite is preferred.
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred.
• Strong critical thinking and discretionary decision-making skills;
• Strong organizational and time-management skills;
• Ability to multi-task and prioritize autonomously in a fast-paced environment;
• Excellent written & oral communication skills;
• Ability and willingness to travel (up to 10% of the time).

Responsibilities of the Clinical Systems Coordinator

The specific duties of the Clinical Systems Coordinator include but are not limited to:

• Configuring, managing, and maintaining Axogen’s Veeva Vault (eTMF, CTMS, Payments, etc.) to meet organizational and regulatory standards.
• Administering user roles, permissions, and access controls for Veeva Vault and related clinical systems to ensure system security and data integrity.
• Collaborating with IT, vendors, and external partners to address technical issues, system upgrades, validation activities, and system enhancements in compliance with Axogen’s Quality Management System.
• Managing metadata for document uploads and coordinating necessary changes with internal teams.
• Monitoring system performance, facilitating integration between clinical systems, and providing troubleshooting and resolution support.
• Assist in initiatives to validate and implement new clinical systems or upgrades, ensuring alignment with GxP standards and organizational objectives.
• Creating and maintaining system configuration guides, workflows, and user manuals to support internal teams and stakeholders.
• Ensuring backups, disaster recovery processes, business continuity plans, and audit trails are in place to maintain compliance and data security.
• Establishing and maintaining system metrics dashboards to monitor user activity, system health, and perform