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Clinical Scientific Expert 1

2+ years
Not Disclosed
10 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Novartis Clinical Scientific Expert 1 (CSE) - Dublin, Ireland
Innovative Medicines, Research & Development

About Novartis
Novartis is at the forefront of transforming healthcare, bringing life-changing medicines to millions worldwide by blending cutting-edge medical science with innovative digital technology. As a global leader, we offer abundant growth opportunities, cross-functional roles, and access to a diverse learning suite with thousands of programs. Our commitment to growth and transformation enables us to quickly deliver groundbreaking medicines to patients in need. Join us in our mission to improve and extend lives.

Role Overview
The Clinical Scientific Expert 1 (CSE) plays a vital role in providing clinical and scientific support throughout all phases of a clinical study, under the guidance of the (A)CD(M)D. The CSE ensures compliance with Novartis processes, ICH GCP, and regulatory standards, while focusing on clinical data review excellence. This role involves identifying trends, signals, and risks related to trial endpoints and patient safety. The CSE is a key member of the Clinical Trial Team (CTT) and supports program-level activities.

Key Responsibilities

  • Conduct high-quality clinical data review, focusing on patient-level insights, trend analysis, subject safety, data integrity, and eligibility.
  • Support interim analysis and Database Lock activities, ensuring accurate and reliable data.
  • Contribute to the development of the Data Review Plan (DRP) and data review strategy.
  • Assist in the development of protocols and CRF design.
  • Drive process improvements in data review and innovative data analysis tools.
  • Support pharmacovigilance activities as needed.
  • Contribute to study documents and submission dossiers.

Essential Requirements

  • MSc in Life Sciences (PhD/MD preferred).
  • Significant scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical studies in both industry and academia.

Why Novartis?
At Novartis, our purpose is to reimagine medicine to improve and extend lives. With the dedication of our team, we aim to become the most valued and trusted medicines company globally. Join us and be part of a mission that fosters collaboration, passion, and a community driven to achieve breakthroughs in healthcare.

Benefits

  • Competitive salary, annual bonus, and pension scheme.
  • Health insurance, 25 days of annual leave, and flexible working options.
  • Subsidized dining facilities, employee recognition, and career development opportunities.

Location
Dublin, Ireland (Hybrid)

Join the Novartis Network
Not the right fit for you? Stay connected and explore future career opportunities by joining our talent network here.

Diversity & Inclusion
Novartis is dedicated to fostering an inclusive environment, with diverse teams representing the patients and communities we serve.

For more information, visit Novartis Careers.