Job Description
Join our award-winning healthcare technology team at MediSolutions Health Group, where innovation meets patient care. We're seeking a Clinical Data Manager to drive data integrity in cutting-edge medical research. You'll work with industry-leading professionals to transform healthcare outcomes through precise data management. Enjoy competitive benefits, flexible work arrangements, and opportunities for professional growth in one of America's top healthcare hubs.
Responsibilities
- Design, implement, and maintain clinical databases using EDC systems (e.g., Medidata Rave)
- Ensure data integrity through rigorous validation checks and SOP adherence
- Collaborate with cross-functional teams to develop data management plans
- Generate quality reports for regulatory submissions (FDA, EMA compliance)
- Lead data migration projects while maintaining audit trail documentation
- Mentor junior data specialists on best practices
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field (Master's preferred)
- 3+ years clinical data management experience in pharmaceutical/biotech
- Proficiency in SAS, R, and SQL for data analysis
- Certification in CDISC standards (SDTM, ADaM)
- Deep understanding of 21 CFR Part 11 and GCP guidelines
- Experience with clinical trial databases and EDC systems
- Exceptional attention to detail and problem-solving skills