Novartis Life Science Drug Development Scientific Expert Job Vacancy
Novartis Life Science Drug Development Scientific Expert Job Vacancy. Clinical Scientific Expert – I jobs for MSc life sciences candidates. Check out all of the details regarding the Scientific Expert vacancy in the Global Drug Development dept given below:
Novartis Vacancy Details
Job Title: Clinical Scientific Expert – I
Job ID: 295641BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: CD&A GDD
Employment Type: Regular
Job Description for Novartis Vacancy:
Your responsibilities:
Your responsibilities consist of, however, are not limited to:
Responsibility for ensuring excellent quality clinical trial data review/insights and also analysis as directed by the Integrated Clinical Trial Team (iCTT).
- Perform premium quality clinical data review and identify clinical data insights with patient-level review and also trends analysis, supporting Interim Analysis, Database and Post Lock activities and also assist in the resolution of clinical data issues. Work together with appropriate line functions to boost the quality of clinical data review/insights with a focus on subject safety and also qualification, data integrity, trend identification, analysis and also remediation, and also the identification of cases for medical review.
- Adds to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, making certain that protocol-level discrepancies, eligibility requirements, study assessments & various other aspects of the protocol are implemented consistently across the study.
- Combined with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture devices.
- Contribute to as well as assist in data review procedure improvements e.g. identification of delinquent/redundant reports and/or implementation of cutting-edge data analysis procedures and also devices.
- May add (in collaboration with relevant line functions) to the development of study-level documents, consisting of clinical sections of crucial regulatory documents, such as Investigator’s Brochures, instruction books, safety updates and also submission files. In partnership with pertinent line functions, review/write clinical trial documents for study CSR tasks, 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 products and offer training to iCTT.
- Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required for the Novartis Vacancy.
- Develop subject matter expertise (disease area knowledge, clinical data review tools and/or procedures).
- Add To Clinical Development and also Analytics (CD&A) line function initiatives, local and/or worldwide education and process development projects, as required.
Minimum Requirements for Novartis Vacancy:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is needed. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD highly preferable. Fluent English (oral and also written)
- 1-2 years scientific, strategic and operational experience in planning, executing, reporting and 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
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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.
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