Clinical Data Specialist

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 Data Specialist

The Clinical Data Specialist supports the full lifecycle of clinical data management activities across Axogen’s clinical studies and reports to the Director, Clinical Data Management & Systems. This role plays a key part in ensuring high-quality, reliable, and inspection-ready clinical data from protocol development through database lock. The Specialist collaborates closely with Clinical Operations, Biostatistics, Medical, and a variety of external data and system vendors to support database design, data review, reconciliation, and study documentation.

Requirements of the Clinical Data Specialist

• Bachelor’s degree in a health science, life science, mathematics, or related field required; master’s degree preferred.
• Minimum 2 years of clinical data management experience in a medical device, biotech, or pharmaceutical environment.
• Experience with EDC systems and core data management activities (CRF design, data review, query management, reconciliation, database updates).
• Understanding of GCP, ICH guidelines, and 21 CFR Part 11 requirements.
• Strong analytical and problem-solving skills with the ability to identify trends and resolve data issues.
• Understanding of database structure and design principles; experience with data visualization tools is helpful.
• Excellent organization and attention to detail for managing study documentation and data workflows.
• Effective communicator with the ability to work across clinical, statistical, medical, and systems partners.
• Ability to manage multiple priorities across studies with consistent follow-through.
• Experience with Veeva Vault Clinical Suite or OpenClinica preferred but not required.

Responsibilities of the Clinical Data Specialist

The specific duties of the Clinical Data Specialist include but are not limited to:

• Protocol Development & Study Start-Up
  • Participate in protocol review to ensure clarity, feasibility, and alignment of data collection requirements.
  • Support CRF design, edit check development, controlled terminology, and study-level data management documentation.
  • Participate in all UAT activities for initial database builds and system configurations.
  • Coordinate with internal partners to align study-level data requirements and workflows.
  • Ensure all start-up documentation is complete and compliant with Axogen standards.

• Data Review, Analysis Support, and Ongoing Study Oversight
  • Conduct ongoing data review to assess accuracy, completeness, and consistency across all clinical and external data streams.
  • Generate, track, and resolve system queries in collaboration with stakeholders.
  • Review reports and dashboards that show study data to identify inconsistencies, missing information, or issues that need follow-up.
  • Participate in routine data review meetings to discuss trends, risks, and outstanding issues.
  • Support Biostatistics with data transfer documentation, issue resolution, a