Job Description
Join MedTech Innovations' cutting-edge healthcare team as a Senior Clinical Data Manager. We're revolutionizing patient outcomes through innovative clinical trials and data-driven solutions. In this pivotal role, you'll oversee end-to-end data management for FDA-regulated studies while mentoring junior team members. Enjoy comprehensive benefits including health insurance, 401(k) matching, and flexible work arrangements. Be part of a culture that values precision, innovation, and patient-centric care.
Responsibilities
- Design and implement clinical database architecture for Phase I-III trials
- Ensure data integrity through SAS programming and validation protocols
- Collaborate with cross-functional teams (Biostatistics, Regulatory, Medical Affairs)
- Develop data management plans (DMPs) and study-specific guidelines
- Manage external CRO partnerships and vendor oversight
- Lead system validation processes for CDISC/SDTM compliance
- Mentor junior data managers and conduct team training
- Participate in FDA audits and regulatory inspections
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharmaceutical/biotech
- Advanced proficiency in SAS, Oracle Clinical, and Rave EDC systems
- CDISC-SDTM/ADaM certification preferred
- Thorough knowledge of 21 CFR Part 11 and ICH-GCP guidelines
- Experience with risk-based monitoring strategies
- Strong project management skills with PMP certification
- Excellent written/verbal communication abilities