Job Description
Join MedTech Innovations as a Clinical Data Manager and revolutionize healthcare outcomes through data-driven decision making. We're seeking a detail-oriented professional to oversee clinical trial data integrity and compliance at our Boston headquarters.
In this pivotal role, you'll collaborate with cross-functional teams to ensure data accuracy, implement CDISC standards, and contribute to life-saving medical research. Our cutting-edge platform serves 500+ healthcare partners, offering you unparalleled career growth in one of America's most innovative medical ecosystems.
Responsibilities
- Design and maintain clinical databases using SAS and Oracle systems
- Ensure compliance with FDA 21 CFR Part 11 and GCP regulations
- Perform data validation and quality control procedures for multi-center trials
- Generate statistical reports and data visualizations for executive stakeholders
- Train clinical research staff on data management best practices
- Collaborate with biostatisticians on protocol development and CRF design
- Manage data transfer processes between EDC systems and clinical warehouses
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field
- 3+ years clinical data management experience in pharmaceutical/medical device
- Certification from Society for Clinical Data Management (SCDM) preferred
- Expertise in CDISC standards (SDTM, ADaM) and SAS programming
- Strong knowledge of FDA regulations and ICH-GCP guidelines
- Experience with EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional attention to detail and problem-solving abilities