Clinical Data Manager
$92k - $115k USD
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 Manager
The Clinical Data Manager performs hands-on clinical data management activities across Axogen’s clinical studies, with primary responsibility for supporting study start-up activities, overseeing data collection, performing data cleaning, and conducting ongoing data review to ensure adherence to study protocols. This role is accountable for maintaining accurate, complete, and inspection-ready clinical data from study start-up through database lock.
The Clinical Data Manager works closely within the core Data Management team and partners with Clinical Operations, Biostatistics, Medical, Clinical Systems, Quality, and external vendors to support eCRF design, edit check development, data review, reconciliation, and regulatory readiness. This is an individual contributor role reporting to the Director, Clinical Data Management & Systems.
Requirements of the Clinical Data Manager
- Bachelor’s degree in a health science, life science, mathematics, or related field required; master’s degree preferred
- 3–6+ years of hands-on clinical data management experience in a medical device, biotech, or pharmaceutical environment
- Experience performing data cleaning, query management, ongoing data review, and reconciliation activities
- Experience working in an Electronic Data Capture (EDC) system required; experience with Veeva EDC preferred
- Working knowledge 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 quality issues
- Ability to manage multiple priorities across studies with consistent follow-through
- Demonstrated ability to work independently while collaborating with Clinical Data Management leadership and cross-functional partners to evaluate issues and align on data management decisions
- Familiarity with CDISC standards and industry best practices preferred
- Certified Clinical Data Manager (CCDM) certification or professional involvement with the Society for Clinical Data Management (SCDM) a plus
- Sponsor-side clinical data management experience preferred
- Experience supporting database lock and regulatory inspections preferred
Responsibilities of the Clinical Data Manager
The specific duties of the Clinical Data Manager include but are not limited to:
- Study Start-Up and Systems Interaction
- Interpret study protocols to support eCRF design and development
- Create and review edit checks to ensure data capture and validation align with protocol requirements
- Review EDC builds and participate in UAT to confirm eCRFs and edit checks function as intended
- Support production release readiness and assess the impact of study changes on data quality and review workflows
- Assess protocol amendments to determine data, eCRF, and edit check impacts and support required database updates
- Partner with Clinical Systems and vendors to review, test, and validate database changes resulting from protocol amendments or system releases
- Data Collection, Cleaning, and Review
- Perform hands-on oversight of clinical data collection activities to ensure alignment with study protocol requirements
- Perform data cleaning and ongoing data review from study start-up through database lock
- Evaluate edit check performance during study conduct and support updates as needed
- Generate, review, prioritize, and resolve queries in collaboration with investigative sites and vendors
- Review data listings and other review outputs to identify discrepancies, trends, and data quality risks
- Track data issues through resolution to support study timelines and database lock readiness
- Perform and support reconciliation of clinical data with external data sources as applicable
- Support post-implementation review of database changes to ensure data integrity and continued protocol adherence
- Collaboration and Execution Support
- Work closely within the core Data Management team, as well as Clinical Operations, Clinical Systems, Biostatistics, Medical Monitoring, Quality, and external vendors to ensure accurate, complete, and inspection-ready clinical data throughout the study lifecycle
- Support interim data reviews, data cuts, and database lock activities
- Communicate data issues clearly and proactively to appropriate stakeholders
- Quality and Compliance
- Perform data management activities in accordance with SOPs, GCP, ICH guidelines, and 21 CFR Part 11 requirements
- Maintain inspection-ready documentation supporting data review, reconciliation, and data quality decisions
- Support audits and inspections by clearly explaining data review activities, decisions, and outcomes
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.
Salary Range
$92,293—$115,367 USD
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.