Job Description
Join our pioneering healthcare technology team at MedTech Innovations, where we're revolutionizing patient care through cutting-edge clinical data solutions. We seek a Senior Clinical Data Manager to oversee complex data operations for our FDA-compliant digital health platform. This hybrid role combines deep clinical expertise with advanced data management skills in a mission-driven environment. You'll collaborate with cross-functional teams to ensure data integrity while contributing to life-changing healthcare innovations. Benefits include: Comprehensive health insurance, 401(k) matching, flexible work arrangements, and $5,000 annual professional development stipend.
Responsibilities
- Design, implement, and maintain clinical databases for multi-center trials
- Ensure GCP/GMP compliance across data management workflows
- Lead data validation and quality assurance processes using SAS and R
- Collaborate with biostatisticians to develop analysis datasets
- Train clinical staff on data management systems and protocols
- Generate regulatory submissions-ready data packages
- Mentor junior data management staff
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in healthcare or pharma
- Certified Clinical Data Manager (CCDM) required
- Expertise in CDISC standards and clinical databases (Oracle MedRDL, Veeva Vault)
- Strong proficiency in SAS programming for clinical data cleaning
- FDA regulatory compliance experience (21 CFR Part 11)
- Knowledge of HIPAA and healthcare data privacy regulations