Senior Clinical Data Manager

🕒 May 19

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🧬 Biotechnology

🤝 B2B

Biotechnology • B2B

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• 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

🎯 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