Offer summary
Qualifications:
Bachelor's degree or equivalent experience, 10+ years in Clinical Data Management, Knowledge of ICH, FDA, GCP regulations, Experience with EDC systems, prefer Medidata, Oncology experience preferred.
Key responsabilities:
- Lead and oversee all Clinical Data Management activities
- Manage internal team and external vendors for projects
- Direct study start-up, conduct, and close-out activities
- Ensure data meets study objectives and quality standards
- Contribute to cross-functional study teams and documentation