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Clinical Scientific Expert I (CSE I)

Statistical Analysis
Pharmacovigilance
Life Sciences
Conditional Random Field
DRP
Database
Data Integrity
Data Analysis
Clinical Trial
Medical Review
Data Collection
Therapeutic
Case Report
Clinical Operations
Clinical Studies
Clinical Study
Drug Development
Pharmd
ICH
GCP
CRF
Description:

This is a temporary contractor opportunity at Novartis 

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 

This role is offered through Magnit Global, who, if selected, will be your employer. If your services are retained, you will be assigned to provide services to Novartis as the end client. This is not an offer of employment with Novartis. If you are selected for this Temporary/External opportunity, you will not be an employee of Novartis and will not be eligible for any Novartis employee benefits or incentives.

 Ready to work with/through Magnit at Novartis? Please read on…

Job Purpose:

The CSE External/Contractor will train as a Clinical Scientific Expert I (CSE I) who provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP, and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The CSE External/Contractor, for the duration of contract as CSE, will be considered a core member of the Integrated Clinical Trial Team (iCTT). The CSE External/Contractor may support program level activities if there is a business need. Training and support will be provided for such activities. 

Major Activities:

Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT):

  • 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 facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/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 development 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.
  • In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
  • May contribute to and facilitate data review process improvements if required by CTT and there is a strong business need. Training, support, and advice should be sought before taking up such tasks. Example could include identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools widely used by CSE Function. May contribute (in collaboration with relevant line functions) to the development of study level documents if required by CTT and there is a strong business need. Training, support, and advice should be sought before taking up such tasks.  May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings [SMT]), if required.  
  • Attend Study level meetings (CTT/DQT/Other meetings), as required. 

Requirements:

  • Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, M. Pharm, PhD, MBBS, BDS, MD strongly preferred
  • 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
  • Intermediate knowledge of planning, executing, reporting, and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution
  • Good knowledge of Good Clinical Practice and drug development processes
  • Strong scientific knowledge in at least one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes)
  • Knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis, and reporting. Experience in Rave and/or OC-RDC is an advantage
  • Analytical / computational background; ability to detect data trends and escalate as appropriate
  • Demonstrates knowledge and application of statistical analysis methodology
  • Demonstrates good medical / scientific writing skills
  • Ability to collaborate across boundaries for shared success
  • Ability to resolve issues or understand when to escalate 
  • Fluent English (oral and written) 

Workload: 37.5 hours/week
Role type: Hybrid
Required start date: August - September 2026
Contract: 6 months

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?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.

QUALIFICATION/ LICENSURE :
  • Work Authorization : N/A
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Dublin, Dublin (On-Site)
Contract Duration 6 month(s)