Job Description
Join MedTech Innovations as a Senior Clinical Data Manager and revolutionize healthcare analytics! We're seeking a visionary professional to spearhead clinical data integrity for cutting-edge medical research projects. You'll collaborate with cross-functional teams to ensure regulatory compliance while driving data-driven decisions that impact patient outcomes. Our Boston headquarters offers state-of-the-art facilities, competitive benefits including health/dental/vision insurance, and opportunities for professional growth through continuous learning programs.
Responsibilities
- Design and implement clinical data management strategies for multi-phase medical trials
- Validate data integrity and ensure compliance with FDA/ICH-GCP standards
- Lead data migration processes between EDC systems (e.g., Medidata Rave, Veeva Vault)
- Develop SOPs and training materials for clinical data operations teams
- Collaborate with biostatisticians to prepare datasets for analysis and reporting
- Conduct data quality audits and implement corrective action plans
- Stay current with evolving eClinical technologies and regulatory requirements
Qualifications
- Bachelor's degree in Health Informatics, Nursing, or related field (Master's preferred)
- 5+ years clinical data management experience in pharmaceutical/medical device industry
- Certification in CDISC standards and proficiency with EDC platforms
- Expertise in data validation rules and clinical database configuration
- Strong understanding of 21 CFR Part 11 compliance requirements
- Experience managing global clinical trial data across multiple sites
- Advanced SQL skills and proficiency in data visualization tools (e.g., Spotfire)
- Excellent problem-solving abilities with attention to regulatory nuances