Job Description
Join our pioneering team at MedTech Innovations, where cutting-edge healthcare solutions meet transformative technology. We're seeking a Senior Clinical Data Manager to drive data integrity in our revolutionary oncology trials. Shape the future of patient outcomes while working in our state-of-the-art Boston facility.
Responsibilities
- Design and implement clinical data management strategies for multi-center oncology trials
- Ensure 100% compliance with FDA 21 CFR Part 11 and CDISC standards
- Lead data validation processes using SAS and Oracle Clinical RDC
- Mentor junior data management staff on SOPs and quality metrics
- Collaborate with biostatisticians on data analysis and reporting
- Conduct internal audits and QC checks for data accuracy
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in oncology trials
- SAS programming certification and Oracle Clinical proficiency
- Expert knowledge of CDISC SDTM and ADaM standards
- Certified Clinical Data Manager (CCDM) credential preferred
- Strong experience with EDC systems (e.g., Medidata Rave)