Senior Clinical Data Coordinator Tech Observer

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for project-specific and departmental document tracking and control activities. This includes reviewing CRF and project-specific documents as per the protocol. Additionally, you will initiate project-specific DMTMF and e-filing, reviewing it regularly. Your role will involve preparing project-specific documents and handling requests/issues from the client and team in coordination with the Project Manager. You will collaborate with CDA in User Acceptance Testing (UAT) to ensure a robust database design. As part of database validation, you will perform procedure verification and create, review, process, and track Data Clarification Forms. This is crucial for updating clinical databases and ensuring data validity according to the protocol. You may need to conduct manual data listings and assist in maintaining documents for Pre-production and Pre-lock audits. Furthermore, you will provide project and process-specific training for subordinates and act as a backup for the Data Manager when required. Your responsibilities will also include assisting in the preparation/review of departmental SOPs, conducting basic QC functions for departmental activities, and ensuring SOP compliance in project deliverables. Lastly, you will be expected to adhere to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies while performing delegated activities. Other responsibilities may be assigned by your reporting head and senior management as needed.,

Posted 1 day ago

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