Clinical Data Svs Associate
Designation: Clinical Data Svs Associate
Qualifications:Bachelor of Pharmacy
Years of Experience:1 to 3 years
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What would you do? 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. Strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. Includes data review and accuracy checks of trial master file table of contents, head quarters, initial full protocol package and amended FPP checklists, end of trial checklists, essential document reconciliation, and clinical study report appendices.
What are we looking for? •Adaptable and flexible •Ability to perform under pressure •Problem-solving skills •Detail orientation •Ability to establish strong client relationship
Roles and Responsibilities: Document Administrators are responsible for carrying out format check of documents requiring eCTD compliance for New Drug Application/Marketing Authorization Submission. The format check ensures that the technical quality of submission documents in eCTD compliant and meets the document format standards (e.g., PDF property checks, good documentation practice and bookmark/hyperlink checks).
Hyderabad
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