Job Description
Join our pioneering team at Global Health Innovations, where cutting-edge medical research meets transformative technology. We're seeking a Senior Clinical Data Manager to lead critical data operations for groundbreaking oncology trials. This role offers the opportunity to shape the future of patient care through rigorous data governance and innovative clinical trial management.
As a key member of our Clinical Operations division, you'll collaborate with world-class researchers, biostatisticians, and regulatory experts to ensure data integrity across multi-center international studies. Our Boston-based hub offers state-of-the-art facilities, flexible work arrangements, and comprehensive benefits including tuition reimbursement and profit-sharing.
Responsibilities
- Design, implement, and maintain comprehensive clinical data management systems for Phase II-III oncology trials
- Lead data validation processes using SAS and Oracle Clinical, ensuring 99.7% data accuracy
- Coordinate with CROs and investigative sites to resolve data discrepancies within SLAs
- Develop and execute electronic Case Report Form (eCRF) specifications per CDISC standards
- Prepare regulatory submissions (FDA/EMA) with complete data quality documentation
- Mentor junior data managers and implement continuous process improvements
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in oncology trials
- Advanced proficiency in SAS programming and Oracle RDC
- Certified Clinical Data Manager (CCDM) or equivalent certification
- Demonstrated expertise in CDISC SDTM/ADaM standards
- Strong regulatory knowledge (ICH-GCP, 21 CFR Part 11)
- Experience managing international multi-center trials