Job Description
Join our pioneering team at Global Health Innovations, where cutting-edge medical research meets transformative patient outcomes. We're seeking a Senior Clinical Data Manager to oversee complex clinical trial data integrity while driving innovation in healthcare technology. This hybrid role offers the opportunity to shape the future of medical data management in a collaborative, mission-driven environment.
Why Global Health Innovations? We pride ourselves on our state-of-the-art research facilities, comprehensive benefits package including 100% health insurance premiums covered, and a commitment to professional development through our annual innovation grants.
Responsibilities
- Design and implement comprehensive clinical database architectures for multi-center trials
- Ensure regulatory compliance (FDA 21 CFR Part 11, ICH-GCP) throughout data lifecycle
- Lead data validation strategies and conduct quality control audits
- Collaborate with cross-functional teams (biostatisticians, clinical investigators) to define data requirements
- Maintain and optimize EDC systems (e.g., Medidata Rave, Veeva Vault)
- Develop and execute data management plans and SOPs
- Mentor junior data management staff and train clinical teams on data protocols
Qualifications
- Masters degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharmaceutical/biotech setting
- Expertise in CDISC standards (SDTM, ADaM) and medical coding (MedDRA, WHODrug)
- Certified Clinical Data Manager (CCDM) or equivalent certification required
- Advanced proficiency in SAS programming for data cleaning and analysis
- Experience with risk-based monitoring and eTMF systems
- Demonstrated success in managing ≥3 concurrent global clinical trials
- Strong project management skills with PMP certification preferred