Job Description
Join our pioneering healthcare technology team as a Senior Clinical Data Manager at MedTech Innovations Group. We're revolutionizing patient outcomes through AI-driven clinical trial platforms. This role offers the opportunity to shape the future of medical data management while working with top-tier healthcare professionals and cutting-edge technology.
As a key member of our Clinical Development division, you'll ensure data integrity across multi-phase oncology trials while mentoring junior staff. Our collaborative environment fosters innovation, with competitive benefits including comprehensive health coverage, 401(k) matching, and professional development stipends.
Responsibilities
- Design and implement comprehensive data management strategies for Phase I-III oncology clinical trials
- Oversee CRF design, database development, and validation processes per FDA 21 CFR Part 11
- Lead data cleaning, query resolution, and quality assurance activities
- Collaborate with biostatisticians on data analysis plans and reporting
- Mentor junior data managers and conduct process improvement initiatives
- Ensure compliance with ICH-GCP and regulatory requirements
- Develop and maintain SOPs for data management workflows
Qualifications
- Master's degree in Health Informatics, Biostatistics, or related field
- 5+ years of clinical data management experience in oncology trials
- Certified Clinical Data Manager (CCDM) certification required
- Expertise in Medidata Rave and Oracle Clinical systems
- Strong knowledge of CDISC standards (SDTM, ADaM)
- Experience with risk-based monitoring and ePRO systems
- Proven ability to manage complex data quality issues
- Excellent cross-functional communication skills