Job Description
Join MedTech Innovations at the forefront of digital healthcare transformation! As a Senior Clinical Data Manager, you'll spearhead the design and implementation of data management strategies for groundbreaking clinical trials. Our Boston-based team is revolutionizing patient outcomes through innovative medical devices and AI-driven analytics. You'll collaborate with cross-functional experts to ensure data integrity, regulatory compliance, and seamless clinical trial execution. Enjoy a competitive compensation package, flexible work arrangements, and the opportunity to impact millions of lives.
Responsibilities
- Design and oversee clinical data management systems for multi-center trials
- Validate and analyze complex datasets ensuring FDA/GCP compliance
- Lead data migration and EDC system optimization projects
- Develop data quality metrics and audit procedures
- Mentor junior data management specialists
- Collaborate with biostatisticians on data visualization and reporting
- Implement CDISC standards and regulatory requirements
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years clinical data management experience in medical devices/pharma
- Expertise in Medidata Rave or equivalent EDC platforms
- CDISC-SDTM/ADaM certification preferred
- Proven track record with FDA audits and 21 CFR Part 11
- Advanced SQL and SAS/Python programming skills
- Strong leadership experience in cross-functional teams