335555BR
Apr 29, 2022
Ireland

Job Description

300+, that is the number of ongoing trials in Global Drug Development. The Global Drug Development (GDD) organisation oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines. We are 11,000 associates worldwide working together to reimagine medicine.

The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under the mentorship of the Clinical Leadership team, in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety.

Your responsibilities:

Your responsibilities include, but are not limited to:

• Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and resolution of issues
• Work to improve the quality of reviews/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
• Contributes to the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study. This could also include support for Case Report Form (CRF) development, and implementation of data capture tools
• Provide insights to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools
• Contribute to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers
• Support the reviewing/writing of clinical trial documents for study CSR activities, and publications where necessary
• Adhoc support for pharmacovigilance activities (e.g. reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT))
• Produce training materials and provide training to the Integrated Clinical Trials Team (iCTT)
• Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others)

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Bachelor degree in life sciences/healthcare (or clinically relevant ) 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 a Clinical Operations/Clinical Scientific role
• Advanced level of Excel and other data analysis / visualization tools (Qliksense, JMP, Spotfire, etc) and methods (coding, data science, working with large data sets) for data collection, analysis and reporting
• Good understanding of global clinical studies in a pharmaceutical company or contract research organisation; or similar experience with an academic research institution
• Good knowledge of Good Clinical Practice and drug development processes and strong scientific knowledge in at least one therapeutic area
• Knowledge of principles of clinical data collection and reporting

Desirable requirements:
• Experience in Clinical Electronic Data Capture (EDC) is an advantage.

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
766 million. That’s how many lives our products touched in 2021. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!


#LI-NOV = Novartis
Global Drug Development
GDO GDD
Ireland
Dublin
Human Resources
Full Time
Regular
No
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335555BR

Clinical Scientific Expert I

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