Novartis Hiring Clinical Scientifc Expert – I degree in life sciences/healthcare Apply now
Your responsibilities include, but are not limited to:
• Responsibility for ensuring high quality clinical trial
data review/insights and analysis as advised by the Integrated Clinical Trial
Team (iCTT)
• Perform high quality clinical data review and identify
clinical data insights through patient level review and trends analysis,
supporting Interim Analysis, Database and Post Lock activities and facilitate
resolution of clinical data issues.
• Collaborate with relevant line functions to improve the
quality of clinical data review/insights with an emphasis on subject safety and
eligibility, data integrity, trend identification, analysis and remediation,
and identification of cases for medical review.
• Chips in to the development the Data Review/Quality Plan
(DRP/DQP) and data review strategy, ensuring that protocol-level deviations,
eligibility criteria, study assessments & other aspects of the protocol are
implemented consistently across the study.
• In conjunction with the relevant line functions, may supply
to Case Report Form (CRF) development, and support the implementation of data
capture tools.
• Chip in to and facilitate data review process improvements
e.g. identification of delinquent/redundant reports and/or implementation of
innovative data analysis processes and tools.
• May supply (in collaboration with relevant line functions)
to the development of study-level documents, including clinical sections of key
regulatory documents, such as Investigator’s Brochures, briefing books, safety
updates and submission dossiers. In collaboration with relevant line functions,
review/write clinical trial documents for study CSR activities, and
publications.
• May support pharmacovigilance activities (e.g.,
reviewing/chipping in to aggregate reports/patient narratives, attendance of
Safety Monitoring Meetings (SMT)), if required. Produce training materials and
provide training to iCTT.
Minimum requirements
• Sophisticated degree in life sciences/healthcare (or
clinically relevant degree) is required. PhD, MBBS, BDS, MD strongly
preferable. Proficient English (oral and written).
• >1 year experience in Pharmaceutical industry/ clinical
research organization. Basic knowledge in planning, executing, reporting and
publishing global clinical studies in a pharmaceutical company or contract
research organization.
• Work experience in clinical operations preferable. Strong
social skills - Ability to work under pressure. Good negotiation and conflict
resolution skills. Collaborates across boundaries for shared success
• Resolve issues with minimal direction and understands when
to raise. Fundamental knowledge of Good Clinical Practice, clinical trial
design, statistics, regulatory processes, and clinical development process
• Strong analytical / computational background. Demonstrates
strong Medical / scientific writing skills. Demonstrates knowledge and
application of statistical analysis methodology and can identify trends and
analyze / interpret / report data optimally.
TO APPLY CLICK HERE
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