348943BR
Jul 14, 2022
India

Job Description

“150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.”

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.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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.

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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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348943BR

Clinical Scientific Expert - I

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