Job Description
Join our pioneering team at Global Health Innovations, where cutting-edge medical research meets transformative patient care. We're seeking a Senior Clinical Data Manager to oversee complex clinical trial data integrity for our oncology research division. This role offers the opportunity to shape the future of healthcare innovation while collaborating with world-class physicians and researchers in Boston's premier medical district.
Why Join Us? Enjoy competitive benefits, flexible work arrangements, and continuous learning opportunities in an environment that values work-life integration.
Responsibilities
- Design and implement robust data management strategies for multi-center oncology clinical trials
- Validate and clean electronic data capture (EDC) systems to ensure regulatory compliance (ICH-GCP, FDA)
- Lead database migration projects and troubleshoot data discrepancies
- Generate statistical reports and data visualizations for FDA submissions
- Mentor junior data management staff and conduct SOP training
- Collaborate with biostatisticians to resolve complex data queries
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years of clinical data management experience in oncology trials
- Expert proficiency in Medidata Rave and Oracle Clinical
- Certified Clinical Data Manager (CCDM) credential preferred
- Deep knowledge of FDA 21 CFR Part 11 compliance
- Experience with CDISC standards (SDTM, ADaM)
- Strong problem-solving skills with attention to detail