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Post : Clinical Scientific Expert - I
Job Description
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 to trial endpoints and patient safety. The CSE I is a core member of the Integrated Clinical Trial Team (iCTT) and may support program level activities as assigned. Responsibility for ensuring 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 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.
2. 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.
3. In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, 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. 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.
6. May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. 7. Produce training materials and provide training to iCTT.
8. Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.
9. Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).
10. Contribute to Clinical Development and Analytics (CD&A) line function initiatives, local and/or global education and process development projects, as required.
Candidate Profile
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master's, PharmD, MPharm, 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.
Additional Information
Experience : 1 years
Qualification : PharmD, MPharm, PhD, MBBS, BDS, MD
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Scientific
End Date : 25th October, 2018
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