Validation Associate JSS Medical Research

0.0 - 1.0 years

1 - 3 Lacs

Faridabad

Work from Office

Role & responsibilities- Prepare and update the Annotation list, Data Validation Plan, Edit check Specifications, and Database /Data Entry Screens as per study requirements. Preparation of Operational manual (EDC Trials) Preparation of CRF Filling Guidelines. Perform query management as per the study requirements including the manual queries raised by the data entry team and medical coder, query generation, and resolution. Quality check form updates and re-verification. Filling the data in 2 CRF(s) or database testing. Validate the external data after uploading it into the database. SAE and Lab data reconciliation. Update self-evident correction queries in self-evident correction form per study requirements. Update reports and trackers regularly or as per study requirements. Any other duties as assigned by the supervisor or department. Skills and Qualifications- Knowledge of: MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

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