Job Description
Join our pioneering healthcare technology team at Global Health Innovations, where we're transforming clinical trials through data-driven solutions. We seek a Senior Clinical Data Manager to oversee end-to-end data processes for cutting-edge medical research initiatives. This hybrid role (3 days onsite in Boston) offers competitive benefits, flexible scheduling, and the opportunity to impact patient outcomes through innovative data management strategies.
Responsibilities
- Design, implement, and validate clinical databases and EDC systems for multi-center trials
- Lead data cleaning, analysis, and reporting to ensure regulatory compliance (FDA/ICH/GCP)
- Coordinate with cross-functional teams including biostatisticians and medical writers
- Develop SOPs and training materials for clinical data management processes
- Perform quality control audits and resolve data discrepancies
- Manage vendor relationships for data capture and reporting technologies
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years clinical data management experience in pharmaceutical/medical device
- Certified Clinical Data Manager (CCDM) or equivalent certification required
- Expertise in Medidata Rave or Oracle RDC systems
- Strong SQL programming and data visualization skills
- Experience with regulatory submissions (eCTD preparation)
- Exceptional problem-solving and communication abilities