Senior Clinical Data Coordinator Job in Navitas Life Sciences
Senior Clinical Data Coordinator
Navitas Life Sciences
4+ weeks ago
- Bengaluru, Bangalore Urban, Karnataka
- Not Disclosed
- Full-time
- Permanent
Job Summary
Skills Required :
Set requirement specifications as per protocol and sponsor specifications to CRF designer and communicate effectively until CRF is finalized and approved by PDMProviding inputs for DB design and consult with other interfacing departments for their necessary inputsPlan and Develop DMP documents in consultation with PDM- appropriate templates to be used, specific changes and additions, discussion with Sponsor representative for their suggestions and inputs for all the annexures. Performing validation of Database.Performing - discrepancy review, query generation and updating of DCFs, database updates,Review and resolve data discrepancies identified by the system or through manual checks as per study validation plan document.Perform manual review on data.Non CRF data reconciliation.SAE reconciliationPerform Quality control as per DMP.Identification and implementation of process improvements in the CDM domain.Team discussion and client meetings.Perform on the functions delegated by PDMCreate and impart trainings/ participate in workshops for CDM team and other departmentsChange management and documentation as per SOP per change in any function/processProject documentation per SOP/function as applicable creation/review/filingReconciliation of DMSF documents with document check list prepared per study.Deliver as per work plan per project assigned by PDM and timely updation of timesheet.Prepare CTQ for individual performance as per Process Documents for periodic self-assessment of goals and objective
Qualification : Life Science Graduate
- Responsible for working in the following functions as per SOP/Sponsors specifications towards project objectives of quality and timelines.
- Understanding of protocol and adherence to the regulatory standards and compliance in the delivery process.
- Responsible to perform in accordance with the project management (Scope and scale as per SOW)
- Contribute towards organizational goals and objectives for the continuous improvement.
- Compliant to reports and metrics set by PDM per project and contribution towards team development.
Skills Required :
Set requirement specifications as per protocol and sponsor specifications to CRF designer and communicate effectively until CRF is finalized and approved by PDMProviding inputs for DB design and consult with other interfacing departments for their necessary inputsPlan and Develop DMP documents in consultation with PDM- appropriate templates to be used, specific changes and additions, discussion with Sponsor representative for their suggestions and inputs for all the annexures. Performing validation of Database.Performing - discrepancy review, query generation and updating of DCFs, database updates,Review and resolve data discrepancies identified by the system or through manual checks as per study validation plan document.Perform manual review on data.Non CRF data reconciliation.SAE reconciliationPerform Quality control as per DMP.Identification and implementation of process improvements in the CDM domain.Team discussion and client meetings.Perform on the functions delegated by PDMCreate and impart trainings/ participate in workshops for CDM team and other departmentsChange management and documentation as per SOP per change in any function/processProject documentation per SOP/function as applicable creation/review/filingReconciliation of DMSF documents with document check list prepared per study.Deliver as per work plan per project assigned by PDM and timely updation of timesheet.Prepare CTQ for individual performance as per Process Documents for periodic self-assessment of goals and objective
Qualification : Life Science Graduate
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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