Clinical Data Manager

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 AxogenFriendly, 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 PurposeOur 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 ManagerThe 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 ManagerBachelor’s degree in a health science, life science, mathematics, or related field required; master’s degree preferred3–6+ years of hands-on clinical data management experience in a medical device, biotech, or pharmaceutical environmentExperience performing data cleaning, query management, ongoing data review, and reconciliation activitiesExperience working in an Electronic Data Capture (EDC) system required; experience with Veeva EDC preferredWorking knowledge of GCP, ICH guidelines, and 21 CFR Part 11 requirementsStrong analytical and problem-solving skills with the ability to identify trends and resolve data quality issuesAbility to manage multiple priorities across studies with consistent follow-throughDemonstrated ability to work independently while collaborating with Clinical Data Management leadership and cross-functional partners to evaluate issues and align on data management decisionsFamiliarity with CDISC standards and industry best practices preferredCertified Clinical Data Manager (CCDM) certification or professional involvement with the Society for Clinical Data Management (SCDM) a plusSponsor-side clinical data management experience preferredExperience supporting database lock and regulatory inspections preferredResponsibilities Of The Clinical Data ManagerThe specific duties of the Clinical Data Manager include but are not limited to: Study Start-Up and Systems InteractionInterpret study protocols to support eCRF design and developmentCreate and review edit checks to ensure data capture and validation align with protocol requirementsReview EDC builds and participate in UAT to confirm eCRFs and edit checks function as intendedSupport production release readiness and assess the impact of study changes on data quality and review workflowsAssess protocol amendments to determine data, eCRF, and edit check impacts and support required database updatesPartner with Clinical Systems and vendors to review, test, and validate database changes resulting from protocol amendments or system releases Data Collection, Cleaning, and ReviewPerform hands-on oversight of clinical data collection activities to ensure alignment with study protocol requirementsPerform data cleaning and ongoing data review from study start-up through database lockEvaluate edit check performance during study conduct and support updates as neededGenerate, review, prioritize, and resolve queries in collaboration with investigative sites and vendorsReview data listings and other review outputs to identify discrepancies, trends, and data quality risksTrack data issues through resolution to support study timelines and database lock readinessPerform and support reconciliation of clinical data with external data sources as applicableSupport post-implementation review of database changes to ensure data integrity and continued protocol adherence Collaboration and Execution SupportWork 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 lifecycleSupport interim data reviews, data cuts, and database lock activitiesCommunicate data issues clearly and proactively to appropriate stakeholders Quality and CompliancePerform data management activities in accordance with SOPs, GCP, ICH guidelines, and 21 CFR Part 11 requirementsMaintain inspection-ready documentation supporting data review, reconciliation, and data quality decisionsSupport audits and inspections by clearly explaining data review activities, decisions, and outcomesLocation111 West Oak Ave., Tampa, FL 33602Benefits/CompensationThis 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—$120,000 USDAxogen 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.