Senior Clinical Data Manager

🕒 Maio 19

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Artivion, Inc.

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1984

🧬 Biotecnologia

🤝 B2B

Biotechnology • B2B

A Artivion, Inc. é uma empresa de tecnologia médica focada no desenvolvimento, fabricação e comercialização de dispositivos cirúrgicos e produtos de biomateriais centrados em aorta e coração. A empresa produz válvulas cardíacas (On-X), sistemas de enxerto de stent arco aórtico e tóraco-abdominal, próteses híbridas (AMDS), aloenxertos e tecidos criopreservados, adesivos cirúrgicos (BioGlue) e ferramentas auxiliares para cirurgia vascular e cardíaca. A Artivion trabalha com cirurgiões cardíacos e vasculares, conduzindo ensaios clínicos e submissões regulatórias para avançar na segurança e eficácia dos dispositivos, atendendo hospitais e centros cirúrgicos globalmente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• Health insurance • Professional development • Flexible work arrangements