Job Description
Join MedTech Innovations, a leader in healthcare data solutions, as we revolutionize patient outcomes through cutting-edge clinical research. We seek a Senior Clinical Data Manager to oversee complex clinical trial data integrity while ensuring compliance with FDA and EMA regulations. This hybrid role offers the opportunity to work with industry-leading electronic data capture systems and contribute to life-changing medical innovations.
Our Boston-based team thrives on collaboration and innovation, offering competitive benefits including comprehensive health coverage, 401(k) matching, and professional development stipends. If you're passionate about data-driven healthcare advancement and possess meticulous attention to detail, we invite you to apply.
Responsibilities
- Design, implement, and maintain clinical databases using Oracle Clinical and Medidata Rave
- Oversee data quality processes including data validation, query management, and resolution tracking
- Ensure compliance with 21 CFR Part 11, ICH-GCP, and CDISC standards
- Collaborate with biostatisticians and clinical research teams to define data requirements
- Generate and analyze clinical data reports for FDA submissions and internal reviews
- Train and mentor junior data management staff on SOPs and system usage
- Lead system validation activities and troubleshoot data discrepancies
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field (Master's preferred)
- 5+ years of clinical data management experience in pharmaceutical or CRO environment
- Expertise in CDISC standards (SDTM, ADaM) and electronic data capture systems
- Certified Clinical Data Manager (CCDM) or equivalent certification required
- Strong proficiency in SQL and data visualization tools (Tableau preferred)
- Demonstrated experience with regulatory submissions (IND/NDAs)
- Exceptional problem-solving skills and attention to detail
- Ability to manage competing priorities in a fast-paced research environment