Job Description
Join Boston Medical Innovations as a Senior Clinical Data Manager and lead transformative healthcare data initiatives. We're seeking a visionary professional to oversee clinical trial data integrity for groundbreaking cardiovascular therapies. This role offers unparalleled opportunity to shape patient outcomes while working with cutting-edge EDC systems and regulatory compliance frameworks.
Our collaborative environment supports career growth through continuous learning programs and industry-leading benefits. You'll be instrumental in ensuring data quality that directly impacts FDA submissions and life-saving treatments.
Responsibilities
- Design and implement comprehensive clinical data management strategies for multi-center trials
- Validate EDC database configurations and resolve data discrepancies with 99.8% accuracy
- Lead cross-functional data review meetings with biostatisticians and medical monitors
- Develop and maintain SOPs compliant with FDA 21 CFR Part 11 and ICH-GCP standards
- Mentor junior data managers and conduct data quality audits
- Generate executive dashboards for clinical trial progress and data quality metrics
- Collaborate with IT on system validation for CDISC-compliant datasets
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharmaceutical/medical device
- Certified Clinical Data Manager (CCDM) or equivalent certification required
- Expertise in Medidata Rave or Veeva Vault EDC systems
- Proven track record with CDIG and CDISC standards implementation
- Strong SQL and SAS programming skills for data manipulation
- Experience managing cardiovascular or oncology trial data preferred
- Excellent communication skills for stakeholder presentations