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Life Sciences Expert Novartis – MSc & PhD Apply Online
Clinical Scientific Expert I
Job ID: REQ-10020654
Date: Nov 06, 2024
Location: India
Summary
- Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance, and performance standards.
- May lead specific aspects of global clinical trial(s) as a core member of the Clinical Trial Team (CTT).
- The Clinical Scientific Expert I (CSE I) provides clinical and scientific support through all phases of a clinical study under guidance, ensuring compliance with Novartis processes, ICH GCP, and regulatory requirements.
- Applies clinical data review excellence to identify data insights, trends, signals, and risks associated with trial endpoints and patient safety.
About the Role
Major Accountabilities:
Your responsibilities include, but are not limited to:
- Ensuring high-quality clinical trial data review, insights, and analysis as directed by the Integrated Clinical Trial Team (iCTT).
- Performing clinical data review and identifying insights through patient-level review and trends analysis, supporting activities like Interim Analysis, Database and Post Lock, and resolving clinical data issues.
- Collaborating with relevant line functions to enhance data review/insights focused on subject safety, eligibility, data integrity, trend identification, and remediation.
- Contributing to the development of the Data Review/Quality Plan (DRP/DQP) and strategy to ensure consistent protocol implementation.
- Assisting in Case Report Form (CRF) development and supporting data capture tool implementation in collaboration with line functions.
- Facilitating data review process improvements, such as identifying delinquent/redundant reports or implementing innovative data analysis tools.
- Supporting study-level documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers) and reviewing/writing clinical trial documents for CSR activities and publications.
- Assisting pharmacovigilance activities (e.g., aggregate reports/patient narratives, Safety Monitoring Meetings) if required.
- Producing training materials and providing training to the iCTT.
Minimum Requirements:
- Advanced degree in life sciences/healthcare required (Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, MD preferred). Fluent in English (oral and written).
- More than 1 year of experience in the pharmaceutical industry or clinical research organization.
- Basic knowledge in planning, executing, reporting, and publishing global clinical studies in a pharmaceutical company or contract research organization.
- Clinical operations experience preferred.
- Strong interpersonal skills and ability to work under pressure.
- Good negotiation and conflict resolution skills.
- Ability to collaborate across boundaries, resolve issues with minimal supervision, and escalate when necessary.
- Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development.
- Strong analytical/computational background and scientific writing skills.
- Knowledge of statistical analysis methodology with the ability to identify trends and effectively analyze, interpret, and report data.
Keywords: Clinical Scientific Expert I, Job Posting, Global Clinical Trial, Clinical Trial Team, Data Review, Pharmacovigilance Activities, Clinical Operations, Novartis. Life Sciences Expert Novartis – MSc & PhD Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
