Job Title
Clinical Data Svs Associate
Job Description
* Aligned with Life Sciences R&D vertical covering research laboratories, clinical trials support, regulatory services, pharmacovigilance and patient services solutions.
* Part of the Clinical, Pharmacovigilance & Regulatory offering, supporting biopharma companies to improve outcomes.
* Focused on collection, integration and availability of data at appropriate quality and cost, performing data management activities including discrepancy review, query generation and resolution.
* Responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines, identifying protocol deviations, performing edit check validation, creating test cases and scripts, carrying out database validation (UAT) against specified CRF/ECRF and managing clinical data management projects.
* Provide medical expertise for trial oversight and safety concerns, including creation, review and validation of protocol requirement specifications per SOP.
Roles and Responsibilities
* Solve routine problems through guidelines.
* Interact within team and with supervisor.
* Receive detailed to moderate level instruction on daily tasks.
* Decisions impact own work.
* Serve as an individual contributor with a focused scope.
* Work may be required in rotational shifts.
Qualifications
* BE/Bachelor of Pharmacy or Master of Pharmacy.
* 1 to 3 years of experience.
Employment Type
Full Time
Job Location
Bangalore
#J-18808-Ljbffr