Job Location: Thane
Key Responsibilities:
1. Clinical Database Development Related Activities:
– Perform database design, program edit checks, external data load set up activities and ensure
successful loading of external data
– Create data listings/ reports for assigned projects.
2. Data Review Related Activities:
– Design/ Create/ provide inputs to CRF, Subject Diary and CRF Completion Guidelines (CCG), —
– Data Validation Plan (DVP) and Self-Evident Correction (SEC) Plan
– Perform User Acceptance Testing (UAT) of clinical database, query management activities, reconciliation of external data from vendors (Lab, ECG etc.) and Serious Adverse Event (SAE) Reconciliation for assigned projects.
3. Compliance to timelines, quality, processes & policies:
– Perform quality control activities as assigned and ensure assigned activities are conducted in
compliance with regulatory requirements and SOPs
– Ensure completeness and correctness of all training records
– Work towards implementation of CDISC standards
4. Support new and existing business:
– Author/Reviewer for SOPs, audit readiness and participation as required
– Escalate issues in timely manner to Line Manager/ Project Manager/ Senior Management as
required
– Ensure timely submission of timesheets/ functional tracking sheets
– Provide suggestions for process improvements that result in time and cost saving and
enhanced quality
– Adhere to SLAs and defined metrics as applicable
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