Related skills
data management gcp sas clinical data management ich guidelines📋 Description
- Oversight of clinical data management for assigned studies per SOPs
- Primary Sponsor contact for data management on study
- Communicate study progress with internal/external project teams
- Oversee CRFs from blank to final delivery to sponsor
- Ensure database setup per specs and perform UAT
- Coordinate Data Management Plan, CRF Guidelines, Data Validation Plan
🎯 Requirements
- High School Diploma or GED; college degree preferred
- 1-2 years industry experience preferred
- Knowledge of GCDMP, GCP, ICH, and 21 CFR Part11
- Knowledge of SAS preferred
- Ability to manage multiple projects/priorities
- Excellent oral and written communication skills
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