Senior Clinical Data Coordinator

Tech Observer

0 years

0 Lacs

hyderabad telangana india

Posted:4 days ago| Platform:

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Skills Required

data tracking management coordination testing database verification processing updating maintenance training qc compliance reporting regulations

Work Mode

On-site

Job Type

Full Time

Job Description

Responsible for project-specific and departmental document tracking and control activities
Reviews CRF (as per protocol) and project-specific documents
Responsible for initiating project-specific DMTMF (Data Management Trial Master File) and e-filing and reviewing it on an ongoing basis.
Responsible for preparing project-specific documents.
Handling requests/issues by the client and team, in coordination with PM.
Coordinates with CDA in User Acceptance Testing (UAT) leading to robust database design.
Performs procedure verification as a part of database validation.
Responsible for creating, reviewing, processing and tracking of Data Clarification Forms and updating clinical databases for ensuring data validity as per the protocol.
Conducts manual data listings as needed.
Assist in maintenance of the documents for Pre-production and Pre-lock audits
Conducts project and process specific training for subordinates.
Acting as a back-up for Data Manager.
Assists in preparation/ review of departmental SOPs.
Conducts basic QC functions for departmental activities.
Ensures SOP compliance in project deliverables.
Other responsibilities as delegated by reporting head & senior management.
Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

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