Job Description
Join our pioneering team at MedTech Innovations where we're transforming clinical trial data into life-saving breakthroughs. As a Senior Clinical Data Manager, you'll drive data integrity for global oncology trials using cutting-edge technology. Collaborate with cross-functional teams to ensure regulatory compliance while mentoring junior staff. Enjoy competitive benefits, flexible work arrangements, and opportunities to present at international conferences.
Responsibilities
- Design, implement, and maintain CDISC-compliant clinical databases
- Lead data cleaning processes and resolve complex data discrepancies
- Collaborate with biostatisticians on data analysis and reporting
- Ensure adherence to 21 CFR Part 11 and ICH-GCP guidelines
- Mentor junior data management staff
- Develop and validate data management specifications
- Contribute to process improvement initiatives
Qualifications
- Master's degree in Biostatistics, Health Informatics, or related field
- 5+ years clinical data management experience in oncology trials
- Expertise in CDISC standards (SDTM, ADaM) and SAS programming
- Proficiency in Oracle Clinical or Medidata Rave
- Certified Clinical Data Manager (CCDM) preferred
- Strong knowledge of FDA/ICH-GCP regulations
- Experience managing global multi-center trials
- Exceptional problem-solving and communication skills