Job Description
Join Boston Medical Innovations, a leader in clinical research, as we pioneer breakthrough therapies in oncology and rare diseases. We seek a Senior Clinical Data Manager to oversee complex data operations for multi-center trials, ensuring regulatory compliance and data integrity. Collaborate with cross-functional teams to transform raw data into actionable insights that accelerate patient care.
Our state-of-the-art facility in Boston's Longwood Medical Area offers cutting-edge technology and a collaborative environment. Enjoy comprehensive benefits including tuition reimbursement, flexible scheduling, and wellness programs.
Responsibilities
- Design, implement, and maintain clinical databases and data management systems compliant with FDA/ICH-GCP standards
- Lead data validation processes, including query resolution and quality assurance checks
- Generate statistical reports and data visualizations for regulatory submissions and internal stakeholders
- Mentor junior data management staff and optimize department workflows
- Collaborate with biostatisticians on data analysis plans and study endpoints
- Ensure audit readiness through meticulous documentation and SOP adherence
- Participate in vendor selection and management of EDC systems
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field (or equivalent experience)
- 5+ years of clinical data management experience in pharmaceutical/biotech setting
- Advanced proficiency in Medidata Rave and SAS programming
- Certified Clinical Data Manager (CCDM) or CDISC certification preferred
- Deep knowledge of 21 CFR Part 11 and CDISC standards
- Experience managing data for oncology or rare disease trials
- Exceptional problem-solving skills and attention to detail
- Strong leadership abilities with proven team management experience