Career for M.Pharm, Ph.D as Clinical Scientifc Expert at Novartis
Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Scientifc Expert - II
Responsibility for high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT):
1. 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 quality of data review with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
2. 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 program.
3. In conjunction with the relevant line functions, contribute to Case Report Form (CRF) development, advocate for new/revised CRFs, and support the implementation of data capture tools.
4. 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.
5. Supports medical and scientific strategic input, and supports development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for Novartis local medical organizations
6. Collaborate with relevant line functions on the development of program and 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, publications and registration dossier submission.
7. Support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance at Safety Monitoring Meetings (SMT)), if required.
8. Produce training materials and provide training to Integrated Clinical Trial Team (iCTT).
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred. Fluent English (oral and written) 2-3 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 5+ years in Clinical Operations/Clinical Scientific role Intermediate to Advanced knowledge with hands-on experience in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution Understanding of principles of well-designed clinical trials, including trial objectives, sample size rationale, defined trial population, methods for eliminating or minimizing bias, biostatistical analysis methods, outcome measures, interpretation of results & ethics Strong scientific knowledge at least in one therapeutic area (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes)
Experience : 2-5+ year
Qualification : Pharm.D, M.Pharm, Ph.D, MBBS, BDS, MD
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th July, 2019
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