Advancing Aortic Technologies with Purpose™
Senior Clinical Data Manager
Location
United States
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Data Manager
Artivion, Inc.
• Lead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s • Develop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents • Oversee database build • Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities • Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors • Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards • Participate in and contribute to protocol development, case report form design, and data flow diagrams • Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD) • Provide study specific reports and data listings on regular basis and for ad-hoc requests • Support audit readiness and participate in regulatory inspections when required • Mentor junior team members and provide strategic input into department process improvements and SOP development
Job Requirements
- Bachelor's or Master’s degree in Life Sciences, Data Science, Computer Science, or a related field
- 7+ years of clinical data management experience, with at least 2 years in a senior or lead role
- Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.)
- Strong understanding of EDC systems and data standards (CDASH, SDTM, CDISC)
- Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR)
- Excellent organizational, leadership, and communication skills
Benefits
- Health insurance
- Professional development
- Flexible work arrangements
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