Job Location: Mumbai (All Areas)
Key Responsibilities:
1. Clinical Database Development Related Activities:
– Perform database design, program edit checks, external data load set up activities and ensure successful loading of external data
– Create data listings/ reports for assigned projects
2. Data Review Related Activities:
– Design/ Create/ provide inputs to CRF, Subject Diary and CRF Completion Guidelines (CCG), Data Validation Plan (DVP) and Self-Evident Correction (SEC) Plan
– Perform User Acceptance Testing (UAT) of clinical database, query management activities, reconciliation of external data from vendors (Lab, ECG etc.) and Serious Adverse Event (SAE) Reconciliation for assigned projects
3. Compliance to timelines, quality, processes & policies:
– Perform quality control activities as assigned and ensure assigned activities are conducted in compliance with regulatory
Preferred candidates : With experience in Start-Up Phase (UAT, Edit Check, CRF design)
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