Novartis is seeking a Clinical Scientific Expert for their Global Drug Development team. The role requires an advanced degree in life sciences/healthcare, with at least one year of experience in the pharmaceutical industry/clinical research organization, basic knowledge in planning, executing, reporting, and publishing global clinical studies, and a solid analytical/computational background. The candidate will ensure high-quality clinical trial data review and insights, contribute to developing data review plans and strategies, and support the implementation of data capture tools. The job title is “Clinical Scientific Expert – I” at Novartis.
Job Title: Clinical Scientific Expert -I
Job ID 363519BR
- Advanced life sciences/healthcare degree (or clinically relevant) is required. Master’s, PharmD, M.Pharma, Ph.D., MBBS, BDS, MD strongly preferable. Fluent in English (oral and written).
- > 1-year experience in the pharmaceutical industry/ clinical research organization – Basic knowledge in planning, executing, reporting, and publishing global clinical studies in a pharmaceutical or contract research organization.
- Work experience in clinical operations is 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.
“150! Clinical scientific experts globally are part of the Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of the highest quality throughout the life cycle of each program across all disease areas. Be part of a dedicated, passionate team that diligently provides clinical and scientific inputs at the 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 directed by the Integrated Clinical Trial Team (ICT)
- 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 facilitating the resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights, emphasizing subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
- Contributes to developing the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other protocol aspects 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., identifying delinquent/redundant reports and implementing 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. Review/write clinical trial documents for study CSR activities and publications in collaboration with relevant line functions.
- May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)).
- Produce training materials and provide training to iCTT.