Deepa Dumbre Email & Phone Number

• Review of study related documents (Clinical Protocol, Data Handling Plan, Data Validation Plan, Data Entry Manual, Annotated CRF and Data management plan) • Drafting of ‘list of questions’.• Running the Validation checks.• Query Management.• Verification of clinical data.• Data Entry.• Performing Quality control checks as per the Nycomed SOPs.• Loading of the Electronic data (Laboratory, Spirometry)• SAE Reconciliation• Other Processes related to Study Finalization (DB Lock)• CRO Coordination: To provide quality inputs for CRO Coordination by reviewing and addressing issues concerning certain study specific documents, such as Study Protocol, CRF and DMP.• Providing status update of the study to seniors as and when required.