Clinical Scientific Expert I
Clinical Scientific Expert I
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Job Description
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Level 3Job Description Summary
The Clinical Scientific Expert I (CSE I) 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 I is a core member of the Integrated Clinical Trial Team (iCTT) and may support program level activities as assigned.Job Description
Your Responsibilities:
- 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 protocollevel 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.
- Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
- May contribute (in collaboration with relevant line functions) to the development of studylevel documents including clinical sections of key regulatory documents such as Investigators Brochures briefing books safety updates and submission dossiers. In collaboration with relevant line functions review/write clinical trial documents for study CSR activities and publications.
What youll bring to the role:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Masters PharmD MPharm PhD MBBS BDS MD strongly preferred.
- Scientific strategic and operational experience in planning executing reporting and publishing clinical studies in industry or Academia or experience in a 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 OCRDC 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
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. to Diversity and Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility & Accommodation : Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an email to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here: Desired
Clinical Research Clinical Trial Protocol Clinical Trials Data Integrity Learning Design Lifesciences Risk Monitoring Trends AnalysisEmployment Type
Full-Time
