Job Description
Join MedTech Innovations, a leader in digital healthcare solutions, as we revolutionize patient care through data-driven innovation. We seek a Clinical Data Manager to oversee clinical trial data integrity and compliance with FDA/ICH-GCP standards. You'll collaborate with cross-functional teams to ensure data quality while driving our mission to accelerate medical breakthroughs. Our Boston hub offers cutting-edge resources and a culture of continuous learning.
Responsibilities
- Manage electronic data capture systems (EDC) for clinical trials
- Ensure data integrity through validation and quality control processes
- Develop and execute data management plans aligned with regulatory requirements
- Collaborate with biostatisticians on data analysis and reporting
- Conduct data audits and resolve discrepancies
- Maintain compliance with 21 CFR Part 11 and GDPR guidelines
- Train clinical teams on data management protocols
Qualifications
- Bachelor's degree in Health Informatics, Biostatistics, or related field
- 3+ years clinical data management experience in medical/pharma
- Proficiency in EDC systems (e.g., Rave, Veeva Vault)
- SAS programming or SQL for data manipulation
- Certified Clinical Data Manager (CCDM) preferred
- Strong understanding of clinical trial workflows
- Excellent attention to detail and problem-solving skills