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Salary Range:
€42,420.00 - €78,780.00
Job Description Summary
Work Arrangement: Hybrid Working, #LI-Hybrid
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
