Clinical Data Specialist

Axogen • Tampa, FL

10h • Onsite

About The Position

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

• 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.

Nice To Haves

• Experience with Veeva Vault Clinical Suite or OpenClinica preferred but not required.

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.

Benefits

• Most benefits are effective on day one!
• 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
• This position is eligible for an annual bonus.
• Benefits offered for this position include 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, and Disability Insurance, as described in more detail in summary plan descriptions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level