Salary Range: €42,420.00 - €78,780.00 Band Level 3 Job Description Summary Work Arrangement: Hybrid Working, #LI-Hybrid Location: Dublin, Ireland Relocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible. ABOUT THE ROLE The 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. Job Description Key

Responsibilities

Perform high-quality clinical data review, including patient-level review and trend analysis, to generate actionable insights supporting interim analyses, database lock, and post-lock activities Identify, investigate, and facilitate resolution of clinical data issues in collaboration with cross-functional teams, ensuring a strong focus on subject safety, eligibility, and data integrity Contribute to the development and execution of Data Review Plans (DRP) / Data Quality Plans (DQP) and associated data review strategies Ensure consistent implementation of protocol requirements across studies, including eligibility criteria, study assessments, and protocol deviations Collaborate with relevant line functions to enhance data quality review processes, including identification and remediation of trends and anomalies Support the development and implementation of Case Report Forms (CRFs) and data capture tools in collaboration with cross-functional partners Contribute to continuous improvement of data review processes, including optimization of reports and adoption of innovative analytics tools and methodologies Support the development and review of study-level documents, including clinical sections of regulatory submissions, Investigator’s Brochures, clinical study reports (CSRs), and publications Participate in pharmacovigilance activities where required, including safety data review, aggregate reports, and Safety Monitoring Team (SMT) meetings Develop training materials and deliver training to iCTT members and study teams on data review processes Support and present data insights at study-level meetings, including Investigator Meetings and Data Monitoring Committee (DMC) meetings, as required Essential

Requirements

Advanced 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 environments Solid understanding of clinical trial protocols and study execution Expertise in clinical data review, data integrity, and data quality management

Experience

performing trend analysis and identifying data insights at the patient and study level Knowledge of good practice GxP and regulatory requirements applicable to clinical data Excellent collaboration skills with the ability to work effectively in cross-functional and matrixed environments Strong communication and presentation skills with the ability to convey complex clinical data insights Desirable

Requirements

Experience

contributing to regulatory documents (e.g., CSRs, Investigator’s Brochures, submissions) Exposure to pharmacovigilance activities and safety data review

Experience

with innovative data analytics tools and visualization platforms Previous experience supporting global clinical trials Why 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-culture

Benefits

and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) Skills Desired Clinical Research, Clinical Trial Protocols, Clinical Trials, Data Integrity, Learning Design, Lifesciences (Inactive), Risk Monitoring, Trend Analysis Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .