Job Description
Join MedTech Innovations at the forefront of digital healthcare transformation! We're seeking a Senior Clinical Data Manager to spearhead data integrity initiatives for our cutting-edge cardiovascular research program. This pivotal role bridges clinical operations and data science, ensuring regulatory compliance while accelerating life-saving innovations. Work in our state-of-the-art Boston facility alongside world-class researchers using AI-driven analytics platforms. Enjoy comprehensive benefits including premium health coverage, flexible scheduling, and professional development stipends.
Responsibilities
- Design and implement clinical data management strategies for multi-center cardiovascular trials
- Validate EDC (Electronic Data Capture) systems and ensure 21 CFR Part 11 compliance
- Lead data cleaning processes and resolve discrepancies with clinical sites
- Generate clinical study reports and FDA submissions
- Mentor junior data managers and optimize CDMP workflows
- Collaborate with biostatisticians on SAS programming for analysis datasets
- Conduct data quality audits and implement corrective actions
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in cardiovascular trials
- Certified Clinical Data Manager (CCDM) or equivalent certification
- Proficiency in Medidata Rave or Veeva Vault EDC systems
- Expert knowledge of ICH-GCP and FDA regulations
- Advanced SAS programming skills for clinical datasets
- Experience with CDISC standards (SDTM, ADaM)
- Demonstrated success in leading cross-functional data teams