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Salary: EUR 42,420 - 78,780 / annual
DTX Pharma, a Novartis Company, is seeking a Clinical Scientific Expert I to provide clinical and scientific support across all phases of clinical studies. This hybrid role is based in Dublin, Ireland.
You will perform high-quality clinical data review at the patient level and conduct trend analysis to generate actionable insights supporting interim analyses, database lock, and post-lock activities. You'll identify, investigate, and facilitate resolution of clinical data issues in collaboration with cross-functional teams, maintaining a strong focus on subject safety, eligibility, and data integrity.
Key responsibilities include contributing to the development and execution of Data Review Plans (DRP) and Data Quality Plans (DQP), ensuring consistent implementation of protocol requirements across studies, and collaborating with line functions to enhance data quality review processes. You will support the development and implementation of Case Report Forms (CRFs) and data capture tools, and contribute to continuous improvement of data review processes through optimization of reports and adoption of innovative analytics tools.
Additionally, you'll support the development and review of study-level documents including clinical sections of regulatory submissions, Investigator's Brochures, and clinical study reports (CSRs). You may participate in pharmacovigilance activities including safety data review and Safety Monitoring Team meetings. You'll develop training materials for integrated clinical trial team members and present data insights at study-level meetings, including Investigator Meetings and Data Monitoring Committee meetings as required.
You are a core member of the Integrated Clinical Trial Team (iCTT) and may support program-level activities as assigned. This role operates in compliance with Novartis processes, ICH GCP guidelines, and regulatory requirements.
