Job Description
Join MedTech Innovations, a leader in digital health solutions, as we revolutionize patient care through data-driven innovation. We seek a meticulous Clinical Data Manager to oversee the integrity of clinical trial datasets and ensure regulatory compliance in our state-of-the-art Boston facility. This hybrid role offers the opportunity to shape healthcare outcomes while working with cutting-edge EHR systems and AI-driven analytics.
Responsibilities
- Design, implement, and maintain clinical databases for multi-phase trials
- Ensure data integrity through validation protocols and SOP adherence
- Collaborate with cross-functional teams to resolve data discrepancies
- Generate regulatory-ready datasets for FDA/EMA submissions
- Lead data migration projects between EHR and research platforms
- Develop automated quality control procedures using SAS/Python
- Mentor junior data specialists on best practices
Qualifications
- MSc in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharma/device
- Certified Clinical Data Manager (CCDM) preferred
- Expertise in CDISC standards and Medidata Rave
- Proficient in SAS programming and data visualization
- Strong knowledge of 21 CFR Part 11/GxP compliance
- Experience with REDCap and Oracle Clinical databases