A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Central CRA
Job Description:
Responsible for central remote monitoring of assigned clinical trial(s) executed by GBS Clinical Trial Services on behalf of Novartis Organizations. Use online data sources to review patient data for consistency, plausibility and completeness. Early identification of potential risks, safety and/or quality issues and trigger required follow-up actions. Ensure high quality and complete data is available.
Minimum requirements
1. Perform ongoing central remote monitoring of patient data using available online data sources (eCRF, IRT, central lab etc.) to ensure consistency and correctness of the data.
2. Communicate any observations, deviations to protocol, safety alerts, quality issues, trends / patterns, risk factors etc. that may affect the planned conduct of the trial to the clinical team and local CRO / directly to site for timely follow-up of actions and issue resolution.
3. Perform data query resolution process (with site, CRO CRA and DM).
4. If / As required, update Clinical Trial Management System or other study management systems.
5. Responsible for writing Monitoring Plans and trial specific tools.
6. Provide input to eCRF design & review, and other documents and systems as applicable, ensuring accurate format for monitoring / central monitoring.
7. Acts as a close partner with the local CRO CRAs and Trial Team. A team member of the clinical trial team (CTT).
8. Interact with DM / programming group and/or other line functions to ensure that efficient tracking and data reports are generated as required with flags and alerts for relevant deviations.
9. As applicable support Trial Manager/ Lead for ongoing medical/scientific review, and ongoing clarification of all remote queries to ensure smooth clinical database locks.
Additional Information:
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
End Date: 31st January, 2015
Apply Through Recruiters Portal>>