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). Core member of the Clinical Trial Team.
- 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 with trial endpoints and patient safety.
- The CSE I is a core member of the Clinical Trial Team (CTT) and may support program-level activities as assigned.
About the Role
Major Accountabilities:
Your responsibilities include, but are not limited to:
- 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 facilitating the 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.
- Contribute to the development of 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.
- Contribute to and facilitate data review process improvements, such as identifying delinquent/redundant reports and/or implementing innovative data analysis processes and tools.
- May contribute (in collaboration with relevant line functions) 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.
- In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
- May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
- Produce training materials and provide training to iCTT.
Minimum Requirements:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, M.Pharma, PhD, MBBS, BDS, MD strongly preferable. Fluent English (oral and written).
- 1 year experience in pharmaceutical industry/clinical research organization. Basic knowledge in planning, executing, reporting, and publishing global clinical studies in a pharmaceutical company or contract research organization.
- Work experience in clinical operations preferable. Strong interpersonal skills. Ability to work under pressure.
- Good negotiation and conflict resolution skills. Collaborates across boundaries for shared success.
- Resolve issues with minimal supervision and understands when to escalate.
- Fundamental knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- Strong analytical/computational background. Demonstrates strong medical/scientific writing skills.
- Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze/interpret/report data effectively.
