Location : Remote
Experience : 4+ Years
Educational Qualifications
Bachelor's degree or related experience
Job Purpose :
This position requires the following critical abilities :
- Knowledge of the drug development process.
- 6+ years’ experience in Data Management, Clinical Programming, or other Clinical Research related fields with a minimum of 4 years’ experience in EDC programming
- Hands-on experience with Veeva(mandatory), Medidata Rave, Oracle Inform, etc.
- Experience programming in CQL, CDB, working with JSON format and / or C# is preferred
- Experience integrating other clinical trial modules (eg : lab, safety, IRT, coding, etc.,) with the EDC system
- Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, R or Python, Data Warehouses, SharePoint)
- Manage edit check specifications and configure edit checks at the trial level
- Execute UAT scripts to test the setup of the clinical study or EDC Platforms
- Configure different instances of study (eg : UAT, production, testing etc.,)
- Facilitate user access requests for study teams
- Set up and manage blinded and unblinded study configurations in EDC
- Serve as SME for all EDC database-related activities at the trial level
- Set up, configure, validate, and integrate other modules within the EDC ecosystem