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.
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. Delivery of high quality data according to agreed timelines, ensuring adherence to international and local regulations and Novartis SOP standards. External & internal customer satisfaction survey
Minimum requirements:
Life Science degree or equivalent or health care discipline. Clinical Trial monitoring experience that provides the required knowledge, skills and abilities Fluent English (oral and written)
1. > 4 years of relevant clinical research experience with knowledge of global drug development process
2. Solid understanding of clinical trial design, trial execution and operations. Basic understanding of medical terminology
3. Knowledge and experience in international standards (GCP/ICH), international (FDA/EMEA) and local regulations
4. Good computer skills (eCRF, EDC, CTMS), experience with remote monitoring and the ability to learn appropriate software
5. Good organizational skills, attention to details and ability to prioritize multiple tasks in order to meet project timelines
6. Attention to detail and quality focused
7. Demonstrated ability to establish effective working relationship in a matrix and multicultural environment
8. Strong customer oriented mindset
Additional Information:
Job ID: 183970BR
Location: Hyderabad
Division: NBS
Business Unit: PLS NBS
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
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