Job Description
Join our pioneering healthcare technology team at Innovate Health Solutions, where we're revolutionizing patient care through innovative data-driven solutions. We're seeking a meticulous Clinical Data Manager to oversee critical data integrity in cutting-edge medical research. This hybrid role offers the opportunity to shape the future of healthcare analytics while working alongside world-class physicians and data scientists. Enjoy comprehensive benefits including premium health insurance, flexible scheduling, and professional development stipends.
Responsibilities
- Design, implement, and maintain clinical databases for multi-center trials
- Ensure compliance with FDA 21 CFR Part 11 and CDISC standards
- Lead data validation processes and resolve discrepancies
- Collaborate with biostatisticians to generate clinical reports
- Maintain audit trails and documentation for regulatory submissions
- Train staff on data management protocols and software
- Coordinate with external vendors for EDC system integration
Qualifications
- Bachelor's degree in Health Informatics, Biostatistics, or related field
- 3+ years of clinical data management experience
- Certification in CDISC standards (e.g., ADaM) preferred
- Expertise in Rave/Medidata or equivalent EDC platforms
- Strong proficiency in SAS or SQL for data analysis
- Demonstrated knowledge of GCP and ICH guidelines
- Exceptional attention to detail and problem-solving skills