Job Description
Join our pioneering team at Harvard Medical Innovations as a Senior Clinical Data Manager, where you'll drive breakthroughs in patient care through cutting-edge clinical trials. We're seeking a meticulous professional to oversee complex data ecosystems across oncology and rare disease studies. This role offers the opportunity to shape regulatory submissions while working with world-class researchers in Boston's premier biomedical district.
Responsibilities
- Design and implement CDISC-compliant data management strategies for multi-phase clinical trials
- Spearhead data validation processes ensuring 99.9% accuracy in EDC systems
- Coordinate with FDA/EMA regulatory bodies for data submission compliance
- Mentor junior data managers while establishing SOPs for global clinical trials
- Lead data quality audits across international study sites
- Develop innovative solutions for real-world data integration
- Present data insights to executive stakeholders and scientific review committees
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years clinical data management experience in pharmaceutical/biotech
- Certified Clinical Data Manager (CCDM) or CDISC-SDTM mastery
- Expertise in Medidata Rave, Oracle Clinical, or equivalent EDC platforms
- Proven track record in FDA 21 CFR Part 11 compliance
- Advanced SAS programming for clinical data analysis
- Strong project management with PMP certification preferred