Job Description (but not limited to)
- 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.
