Clinical Data Specialist
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1 Vacancy
Job Summary
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 youll love working atAxogen:
- Friendly openandfunteam culturethat values uniqueperspectives
- Company-wide dedicationto profoundly impacting patients lives
- Comprehensive high-quality benefitspackage effective on date of hire
- Educationalassistanceavailable for all employees
- Matching 401(k)retirementplan
- Paid holidaysincluding floating holidaysto 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 Axogens 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
- Bachelors degree in a health science life science mathematics or related field required; masters 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 theClinical 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 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.
- Database Maintenance Amendments and Study Close-Out
- 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.
- Systems Documentation and Process Support
- 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.
Location
111 West Oak Ave. Tampa FL 33602
#LI-AC1
Benefits/Compensation
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.
Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Required Experience:
IC
Key Skills
- GIS
- Computer Data Entry
- Facilities Management
- ADMA
- Fleet
- Key Account
About Company
Nerve repair has evolved. See what Axogen’s contemporary nerve repair solutions can do for you.
