Clinical Data Manager

Axogen is committed to building 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.

Requirements

• 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

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