Job Description
Join Mayo Clinic's pioneering Clinical Data Management team where innovation meets patient care. We're seeking a Senior Clinical Data Manager to oversee complex clinical trial data integrity across multi-center studies. This role offers hybrid work arrangements with competitive benefits and opportunities to shape the future of healthcare data science.
As part of our world-class research organization, you'll work with cutting-edge EDC systems and collaborate with leading physicians and biostatisticians. Mayo Clinic offers unparalleled professional development, comprehensive health coverage, and retirement benefits including 401(k) matching.
Responsibilities
- Design and implement clinical database structures for phase I-III trials
- Validate data accuracy against protocol specifications and regulatory standards
- Train clinical sites on data capture procedures and CRF completion
- Generate data quality reports for FDA submissions and internal audits
- Lead system testing and validation for EDC platforms (e.g., Medidata Rave)
- Collaborate with biostatisticians on data analysis specifications
- Maintain compliance with 21 CFR Part 11 and ICH-GCP guidelines
Qualifications
- Bachelor's degree in Health Informatics, Nursing, or related field (Master's preferred)
- 5+ years clinical data management experience in pharma/device industry
- Certification from ACRP or SoCRA required
- Expertise in Medidata Rave, Oracle Clintrial, or Veeva Vault RIM
- Strong knowledge of CDISC standards (SDTM, ADaM)
- Experience with SAS or R for data validation programming
- Demonstrated success in leading multi-center trial data management
- Excellent problem-solving skills with attention to regulatory nuances