Job Description
Join MedTech Solutions Inc., a leader in innovative healthcare technology, as we revolutionize patient data management systems. We're seeking a Senior Clinical Data Manager to oversee critical clinical trial data integrity and compliance. This role offers the opportunity to shape the future of healthcare analytics while working with cutting-edge technologies in a collaborative, mission-driven environment. Enjoy competitive benefits, professional development opportunities, and the chance to make a tangible impact on patient outcomes.
Responsibilities
- Design, implement, and maintain clinical database systems ensuring FDA 21 CFR Part 11 compliance
- Lead data validation processes and resolve discrepancies across multi-center clinical trials
- Collaborate with cross-functional teams including biostatisticians and regulatory affairs specialists
- Develop and execute clinical data management plans and SOPs
- Conduct regular audits and generate comprehensive data quality reports
- Maintain electronic Case Report Forms (eCRFs) using Medidata Rave and Veeva Vault RIM
- Train and mentor junior data management staff on best practices
Qualifications
- Bachelor's degree in Health Informatics, Life Sciences, or related field (Master's preferred)
- 5+ years of clinical data management experience in pharmaceutical or medical device industry
- Certification as a Certified Clinical Data Manager (CCDM) required
- Expertise in CDISC standards (SDTM, ADaM) and SAS programming
- Proven experience with EDC systems (Medidata, Veeva) and data validation tools
- Deep knowledge of GCP, FDA regulations, and ICH guidelines
- Exceptional problem-solving skills and attention to detail
- Strong leadership experience with cross-functional teams