Job Description
Join MedTech Innovations Inc., a leader in digital healthcare solutions, as we revolutionize patient data management systems. We seek a Senior Clinical Data Manager to oversee complex clinical trial datasets and ensure regulatory compliance. This hybrid role offers the opportunity to shape the future of healthcare analytics while working with cutting-edge technology in our state-of-the-art Boston facility.
Our ideal candidate thrives in dynamic environments and possesses deep expertise in clinical data workflows. You'll collaborate with cross-functional teams including biostatisticians, regulatory affairs specialists, and medical writers to deliver high-quality datasets that drive life-changing medical innovations.
Responsibilities
- Design, implement, and maintain clinical database systems for multi-phase trials
- Ensure data integrity through rigorous validation checks and audit trails
- Generate comprehensive data reports for FDA submissions and internal stakeholders
- Mentor junior data management staff and develop departmental SOPs
- Coordinate with CROs to oversee external data management activities
- Lead data migration projects during system upgrades
- Stay current with evolving FDA 21 CFR Part 11 and ICH-GCP requirements
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharmaceutical or device setting
- Advanced proficiency in Medidata Rave and Oracle Clinical
- Certified Clinical Data Manager (CCDM) preferred
- Demonstrated experience with SDTM/ADaM standards
- Strong SQL and SAS programming skills
- Exceptional attention to detail and problem-solving abilities
- Experience managing global multi-center trials