Clinical Data Insight Specialist I

Novartis; Lavamünd; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Novartis in Austria is seeking a Clinical Scientific Expert I to support global clinical trial activities, focusing on data review, safety signals and data integrity.

The role contributes to data review plans, CRF development, and cross-functional collaboration to ensure high-quality study outcomes in compliance with ICH-GCP and regulatory requirements.

Strong scientific background and experience with data systems (EDC, Excel) are valued as you support trial teams and documentation across phases.

Qualifikationen

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
• 1–2 years scientific, strategic and operational experience in planning, executing, reporting, and publishing clinical studies in industry or Academia, or 3–4 years in Clinical Operations/Clinical Scientific role
• Good knowledge of Good Clinical Practice and drug development processes.
• Strong scientific knowledge in at least one therapeutic area (e.g., diseases, endpoints, outcomes).
• Knowledge of clinical data collection and reporting; ability to use systems (e.g., EDC) for data collection and reporting; experience with Rave and/or OC-RDC is an advantage.

Aufgaben

• Perform high quality clinical data review and identify insights through patient-level review and trends analysis.
• Contribute to the Data Review/Quality Plan and data review strategy across the study.
• Assist with Case Report Form (CRF) development and data capture tool implementation.
• Contribute to data review process improvements and new analyses/tools.
• Support development of study documents for regulatory submissions and publications.
• Support pharmacovigilance activities if required.
• Produce training materials and present at study-level meetings.
• Develop subject matter expertise in disease areas and data review tools.
• Collaborate across functions for process development and education.

Kenntnisse

Clinical Research

Clinical Trials

Data Integrity

Learning Design

Risk Monitoring

Ausbildung

Advanced degree in life sciences/healthcare

Tools

Rave

OC-RDC

Excel

Jobbeschreibung

Novartis in Austria is seeking a Clinical Scientific Expert I to support global clinical trial activities, focusing on data review, safety signals and data integrity.

The role contributes to data review plans, CRF development, and cross-functional collaboration to ensure high-quality study outcomes in compliance with ICH-GCP and regulatory requirements.

Strong scientific background and experience with data systems (EDC, Excel) are valued as you support trial teams and documentation across phases.