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Skill required: Clinical Data Operations - Clinical Database Testing
Designation: Clinical Data Svs Analyst
Qualifications: BE/Master of Engineering
Years of Experience: 3 to 5 years
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings – Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.
The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.
Participate in regular project meetings and provide input on UAT timelines. Identify test case scenarios with SME/Business System Owners (BSO). Design, develop and maintain automated UAT Test scripts using TOSCA. Execute automated test cases, analyze results and report defects. Responsible for pre dry run of test cases as part of Test Case Development. Responsible for conducting UAT meetings with client stakeholders. Responsible for executes Test cases review. Responsible for status communication of UAT. Responsible for participation in Defect Resolution and Closeout Activities.
BE, Master of Engineering