Job Description
Join Boston Medical Innovations, a leader in clinical research and healthcare technology, as we revolutionize patient outcomes through data-driven solutions. We seek a meticulous Clinical Data Manager to oversee the integrity of clinical trial datasets, ensuring compliance with FDA regulations and international standards. This role offers the opportunity to work with cutting-edge electronic data capture systems while contributing to life-changing medical breakthroughs. Our collaborative environment values innovation and professional growth, with comprehensive benefits including health insurance, retirement plans, and continuing education stipends.
Responsibilities
- Design, implement, and maintain clinical database structures using Oracle Clinical and Rave EDC systems
- Perform data validation, quality checks, and anomaly resolution per ICH-GCP guidelines
- Collaborate with biostatisticians to generate clean datasets for analysis and reporting
- Ensure 21 CFR Part 11 compliance through audit trail management and electronic signature oversight
- Develop data management plans and data validation specifications for Phase I-IV trials
- Mentor junior data management staff and conduct SOP training
- Interface with regulatory affairs to support FDA submissions and audit preparations
Qualifications
- Bachelor's degree in Health Informatics, Statistics, or related field (Master's preferred)
- 3+ years clinical data management experience in pharmaceutical/biotech setting
- Proficiency in Oracle Clinical, Rave EDC, and SAS programming for data cleaning
- Certified Clinical Data Manager (CCDM) or CDISC-SDTM certification required
- Deep understanding of FDA 21 CFR Part 11, ICH-GCP, and CDISC standards
- Exceptional attention to detail with demonstrated problem-solving abilities
- Strong written/verbal communication skills for cross-functional collaboration