Job Description
Join our pioneering team at Global Health Innovations, where we're revolutionizing patient outcomes through cutting-edge clinical research. As a Senior Clinical Data Manager, you'll lead data integrity initiatives for groundbreaking oncology trials while mentoring a dynamic team of data professionals. Enjoy competitive benefits, flexible work arrangements, and the opportunity to shape the future of healthcare technology.
Responsibilities
- Design and implement CDISC-compliant data management strategies for multi-center clinical trials
- Spearhead data quality assurance processes including validation checks and discrepancy resolution
- Lead cross-functional collaboration with biostatisticians and regulatory affairs teams
- Mentor junior data managers and conduct comprehensive training on EDC systems
- Ensure 21 CFR Part 11 compliance for electronic data capture systems
- Generate and maintain study-specific data management plans and SOPs
- Present data quality metrics to steering committees and regulatory authorities
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years of clinical data management experience in oncology trials
- Certified Clinical Data Manager (CCDM) required
- Expertise in Medidata Rave and Oracle Clinical systems
- Proven experience leading cross-functional data teams
- Deep understanding of CDISC standards (SDTM, ADaM)
- Strong knowledge of ICH-GCP and FDA regulatory requirements