Job Description
Join MedTech Innovations Inc. as a Senior Clinical Data Manager and lead the future of healthcare innovation! We're seeking a detail-oriented professional to oversee end-to-end clinical trial data management, ensuring compliance with FDA/EMA regulations while driving data integrity for breakthrough therapies. This hybrid role offers competitive compensation, comprehensive benefits, and opportunities to shape clinical research standards.
Responsibilities
- Design, implement, and maintain clinical databases using Oracle Clinical/Medidata Rave
- Develop data management plans and validation strategies for global trials
- Lead data cleaning, query management, and resolution processes
- Collaborate with biostatisticians on analysis-ready datasets
- Ensure CDISC compliance (SDTM/ADaM) and GCP adherence
- Mentor junior data management staff
- Implement data quality metrics for continuous improvement
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field (Master's preferred)
- 5+ years clinical data management experience with 2+ in leadership
- Expertise in CDISC standards and regulatory guidelines (FDA/EMA)
- Proficiency in clinical trial systems (Medidata Rave, Oracle Clinical)
- Strong SQL and data validation skills
- Certification in clinical data management (e.g., CDISC)
- Experience with oncology or rare disease trials