Job Description
Join our award-winning healthcare technology team at MediTech Solutions, where innovation meets patient care. We're seeking a Senior Clinical Data Manager to lead critical data integrity initiatives for cutting-edge clinical trials. You'll be instrumental in shaping the future of medical research while working with top-tier professionals in a collaborative, mission-driven environment.
Our Boston-based headquarters offers state-of-the-art facilities, comprehensive benefits, and a culture that values work-life balance. As part of our commitment to excellence, you'll receive ongoing professional development opportunities and participate in groundbreaking projects that directly impact global healthcare outcomes.
Responsibilities
- Design, implement, and maintain complex clinical databases for multi-center trials
- Ensure data integrity through rigorous validation checks and quality control protocols
- Collaborate with cross-functional teams to define data specifications and report requirements
- Lead data migration and integration processes for legacy systems
- Develop and maintain SOPs compliant with FDA 21 CFR Part 11 and ICH-GCP standards
- Mentor junior team members and conduct data management training sessions
- Generate and present data analysis reports to stakeholders and regulatory bodies
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years of clinical data management experience in pharmaceutical or CRO setting
- Expertise in Medidata Rave, Oracle Clinical, or equivalent EDC platforms
- Strong understanding of CDISC standards (SDTM, ADaM) and medical terminology
- Proven track record of managing complex data quality initiatives
- Certified Clinical Data Manager (CCDM) preferred
- Exceptional problem-solving skills with attention to detail
- Experience working with oncology or rare disease trials highly desirable