Job Description
Join MediSolutions Group's cutting-edge healthcare innovation team as a Senior Clinical Data Manager. We're revolutionizing patient outcomes through AI-driven clinical trials and precision medicine initiatives. In this pivotal role, you'll safeguard data integrity while accelerating breakthrough treatments for chronic diseases. Our Boston headquarters offers collaborative workspaces with state-of-the-art technology and direct partnerships with leading medical institutions.
We provide comprehensive benefits including health/dental/vision insurance, 401k matching, professional development stipends, and flexible hybrid work arrangements. MediSolutions is committed to diversity, equity, and inclusion in healthcare innovation.
Responsibilities
- Design and implement compliant clinical databases using CDISC standards for global trials
- Oversee data cleaning, validation, and query resolution processes across 15+ concurrent studies
- Lead cross-functional collaboration with biostatisticians, regulatory affairs, and clinical research teams
- Develop SAS programming scripts for data analysis and regulatory submissions (FDA/EMA)
- Maintain audit trails and ensure adherence to 21 CFR Part 11 and GCP guidelines
- Mentor junior data managers and optimize departmental workflows using Agile methodologies
Qualifications
- Bachelor's degree in Health Informatics, Biostatistics, or related field (Master's preferred)
- 5+ years clinical data management experience in pharmaceutical or CRO environment
- Expertise in Oracle Clinical, Medidata Rave, and SAS programming (Base/Advanced)
- Certification in CDISC SDTM/ADaM standards and/or CDISC-CCDM
- Proven track record in managing complex oncology or rare disease trials
- Strong knowledge of ICH-GCP, FDA regulations, and international data privacy laws
- Exceptional problem-solving skills with attention to data integrity nuances