Sr. Clinical Data Manager

Role: Senior Clinical Data Manager overseeing data management for medical device clinical trials, ensuring data integrity from study start-up to database lock. Responsibilities: lead end-to-end data activities, develop and maintain study documents, oversee database build, testing, and validation; collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory, QA, and CROs; ensure compliance with GCP, FDA, MDR/IVDR standards; support audits and regulatory inspections; mentor junior staff and contribute to process improvements. Requirements: Bachelor’s or Master’s in Life Sciences, Data Science, or related field; 7+ years in clinical data management with 2+ years in a senior/lead role; experience with medical device or combination product trials (IDE, PMA, 510(k)); strong EDC, CDASH, SDTM, and CDISC knowledge; understanding of regulatory standards (FDA, EMA, ISO 14155, GDPR). Preferred: experience in FDA-regulated/ISO-certified environments; proficiency in data visualization and analytics tools (Python, R). HighValue: medical device (vascular/surgical), clinical trials, GCP, FDA/EMA compliance, database management, cross-functional collaboration. WorkSetup: not specified.