Job Description
Join MedTech Innovations, a leader in digital health solutions, as we revolutionize patient care through cutting-edge clinical data management. We're seeking a detail-oriented Clinical Data Manager to oversee the integrity of critical healthcare datasets for our FDA-regulated clinical trials. This hybrid role offers the opportunity to shape the future of medical research while working with world-class professionals in Boston's thriving biotech corridor.
Responsibilities
- Design, implement, and maintain robust clinical databases for multi-phase trials
- Ensure compliance with FDA 21 CFR Part 11 and ICH-GCP standards
- Lead data validation processes and resolve discrepancies with CRO partners
- Generate insightful reports for cross-functional stakeholders including biostatisticians
- Train clinical staff on EDC systems and data management best practices
- Collaborate with IT to optimize database security and performance
Qualifications
- Bachelor's degree in Health Informatics, Nursing, or related field (Master's preferred)
- 3+ years of clinical data management experience in pharmaceutical/biotech
- Certification in CDISC standards (SDTM/ADaM) required
- Proficiency in Medidata Rave or equivalent EDC platforms
- Strong knowledge of clinical trial protocols and regulatory requirements
- Advanced SQL and SAS programming skills
- Exceptional attention to detail and problem-solving abilities