Validation Associate

JSS Medical Research

0 - 1 years

1 - 3 Lacs

Faridabad

Posted:1 day ago| Platform:

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Skills Required

Data Validation Sae Reconciliation ecdt development

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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