Clinical Scientific Expert I

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