Major accountabilities:

Your responsibilities include, but are not limited to:

• Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed 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 enhance 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.
• Contributes 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 contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
• Contribute 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 contribute (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/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
• Produce training materials and provide training to iCTT.

Minimum Requirements:

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable. Fluent 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 interpersonal skills – Ability to work under pressure
• Good negotiation and conflict resolution skills – Collaborates across boundaries for shared success – Resolve issues with minimal supervision and understands when to escalate – 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 effectively.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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