-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. -Applicable to Clinical Scientific Expert IThe 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 Clinical Trial Team (CTT) and may support program level activities as assigned.
About the Role
Major Accountabilities:
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.
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 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. Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).
Contribute to line function initiatives, local and/or global education and process development projects, as required.
Essential Requirements
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, 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 and good medical / scientific writing skills
Ability to collaborate across boundaries for shared success and resolve issues or understand when to escalate
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?
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB)
... strategies to ensure quality deliverables, About the Role Key Responsibilities • Lead functional activities for medium to large-sized projects in phase I to IV clinical studies within the Novartis Global Development Organization. • Coordinate activities of Data Managers, both internally and externally. • Make data management ...
... oversight, and delivery of early phase clinical trials. The CPM serves as the operational leader for assigned studies, partnering cross-functionally with the Clinical Development Lead / Clinical Scientist, Drug Safety, Regulatory, Data Management, Quality, and external vendors to ensure clinical trials are delivered on time, ...
... efficiency, and supply chain logistics through advanced analytics. Operating at the intersection of biotechnology and data science, our team leverages large-scale clinical datasets to drive innovation and improve patient outcomes across international https://jobeax.com/link/vp9Rp5T1yNLBC4ko Overview : As a Data Scientist based ...
Job Title: R&D Scientist / Engineer – Reagents (Clinical Chemistry, ABG, FIA, CLIA) Location: Hyderabad, India Department: Research & Development – Diagnostics Experience: 2–8 years (level mapped to seniority; freshers with https://jobeax.com/link/dG8yP0JQtNcQufc1 considered for junior roles) Employment Type: Full-time, ...
... architectures to complex clinical and operational intake workflows, helping automate decision-making, improve data quality, and reduce administrative burden for clinical teams. In this role, you will partner closely with clinical operations, product, and engineering teams to uncover hidden drivers, inform strategic decisions, ...
Senior Global Regulatory Scientist- Office based- India ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work ...
... organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Senior Medical Data Reviewer at ICON, you will provide expert medical oversight of clinical trial data, ...
... investigator’s brochure, study plans etc. Required Skills and Experience - Minimum of 5+ years in drug development with at least 3 years in early phase clinical development with hands-on modeling & simulation experience preferred. - Sound understanding of regulatory guidelines in model informed drug development and clinical requirements, ...
... May be involved in review and QC clinical data sections for abstracts / manuscripts/ oral and poster presentations - Will collaborate closely with Regeneron Clinical Scientists, Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities prior to data cuts for snapshots, interim ...
Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead ...