Job Description
Transform Healthcare Innovation with MedTech Innovations
Join our pioneering team as a Senior Clinical Data Manager at MedTech Innovations, where cutting-edge technology meets life-changing healthcare solutions. Based in Boston's renowned Longwood Medical Area, you'll lead data strategy for revolutionary clinical trials that directly impact patient outcomes. We offer competitive compensation, comprehensive benefits, and unparalleled opportunities for professional growth in one of the world's most dynamic healthcare ecosystems.
Responsibilities
- Design and implement comprehensive data management strategies for multi-phase clinical trials
- Oversee CDISC-compliant database development and validation processes
- Lead data cleaning, quality assurance, and regulatory compliance initiatives
- Collaborate with cross-functional teams including biostatisticians and clinical investigators
- Develop and execute data management plans aligned with FDA/ICH-GCP standards
- Mentor junior data managers and optimize departmental workflows
- Present complex data insights to executive stakeholders and regulatory bodies
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years clinical data management experience in pharmaceutical/biotech
- Expertise in CDISC standards (SDTM, ADaM) and EDC systems (Rave, Medidata)
- Strong SAS programming skills for data manipulation and analysis
- ICH-GCP and FDA regulatory compliance knowledge
- Experience with clinical trial data validation and error resolution
- Project management certification (PMP) preferred
- Proven ability to lead complex data initiatives in regulated environments