Clinical Scientific Expert I

Work Arrangement: Hybrid Working, #LI-HybridLocation: Dublin, IrelandRelocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible.ABOUT THE ROLEThe Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study in compliance with Novartis processes, International Council for Harmonization - Good Clinical Practice (ICH GCP_ and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE I is a core member of the Integrated Clinical Trial Team (iCTT) and may support program level activities as assigned.

Key ResponsibilitiesPerform high-quality clinical data review, including patient-level review and trend analysis, to generate actionable insights supporting interim analyses, database lock, and post-lock activitiesIdentify, investigate, and facilitate resolution of clinical data issues in collaboration with cross-functional teams, ensuring a strong focus on subject safety, eligibility, and data integrityContribute to the development and execution of Data Review Plans (DRP) / Data Quality Plans (DQP) and associated data review strategiesEnsure consistent implementation of protocol requirements across studies, including eligibility criteria, study assessments, and protocol deviationsCollaborate with relevant line functions to enhance data quality review processes, including identification and remediation of trends and anomaliesSupport the development and implementation of Case Report Forms (CRFs) and data capture tools in collaboration with cross-functional partnersContribute to continuous improvement of data review processes, including optimization of reports and adoption of innovative analytics tools and methodologiesSupport the development and review of study-level documents, including clinical sections of regulatory submissions, Investigator’s Brochures, clinical study reports (CSRs), and publicationsParticipate in pharmacovigilance activities where required, including safety data review, aggregate reports, and Safety Monitoring Team (SMT) meetingsDevelop training materials and deliver training to iCTT members and study teams on data review processesSupport and present data insights at study-level meetings, including Investigator Meetings and Data Monitoring Committee (DMC) meetings, as requiredEssential RequirementsAdvanced degree in Life Sciences, Healthcare, or a clinically relevant field (e.g., MSc, PharmD, MPharm, PhD, MBBS or equivalent)Strong experience in clinical research and clinical trial environmentsSolid understanding of clinical trial protocols and study executionExpertise in clinical data review, data integrity, and data quality managementExperience performing trend analysis and identifying data insights at the patient and study levelKnowledge of good practice GxP and regulatory requirements applicable to clinical dataExcellent collaboration skills with the ability to work effectively in cross-functional and matrixed environmentsStrong communication and presentation skills with the ability to convey complex clinical data insightsDesirable RequirementsExperience contributing to regulatory documents (e.g., CSRs, Investigator’s Brochures, submissions)Exposure to pharmacovigilance activities and safety data reviewExperience with innovative data analytics tools and visualization platformsPrevious experience supporting global clinical trialsWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB)