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.
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
clinicalresearch 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.
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