axogen · 12 hours ago
Clinical Data Specialist
Tampa, Florida, United States
Full-time
Onsite
Entry, Mid Level
$57K/yr - $71K/yr
2+ years expAxogen is committed to building and maintaining a strong company culture that fosters professional growth. The Clinical Data Specialist supports the full lifecycle of clinical data management activities across clinical studies, ensuring high-quality, reliable data from protocol development through database lock.
BiotechnologyMedicalMedical Device
Responsibilities
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
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, and review of data structures during interim and final analyses
Assist with medical coding review to confirm accuracy and consistency
Support safety data workflows, including SAE reconciliation and alignment between clinical and safety systems
Document all data review activities in accordance with inspection readiness expectations
Contribute to risk-based data review by identifying trends, issues, and potential quality concerns
Assess protocol amendments for impact on data collection, database structure, and workflows
Participate in UAT for all mid-study updates, including protocol amendments and changes to integrations or data flows
Support change control documentation and ensure validation steps are complete and traceable
Contribute to final data cleaning, query resolution, reconciliation, and lock readiness activities
Support delivery of clean, complete datasets to Biostatistics for interim and final analyses
Ensure all data management documentation is complete, consistent, and audit-ready
Assist in preparing final data transfers and documentation required for regulatory submissions
Support activities including system validation, internal training, user support, and documentation in eTMF
Participate in inspection readiness activities, including data traceability checks, system documentation review, and eTMF updates
Assist in the maintenance and creation of SOPs, work instructions, templates, and process improvements
Support implementation and optimization of EDC platforms and Veeva Vault Clinical Suite tools
Help generate metrics and dashboards to monitor data quality and study progress
Assist in training internal team members on data management processes, systems, and study-specific expectations
Qualification
Required
Bachelor's degree in a health science, life science, mathematics, or related field required
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
Preferred
Master's degree preferred
Experience with Veeva Vault Clinical Suite or OpenClinica preferred but not required
Benefits
Health
Dental
Vision
Matching 401K
Paid Time Off
9 Paid Holidays + 3 Floating Holidays
Dependent Care Flexible Spending Accounts
Medical Flexible Spending Accounts
Tuition Reimbursement
Paid Parental Leave
Paid Caregiver Leave
Basic Life Insurance
Supplemental Life Insurance
Employee Stock Purchase Plan
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$255.92MKey Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
BioWorld Financial Watch
2026-01-25
legacy.thefly.com
2026-01-23
BioWorld Financial Watch
2026-01-23
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