Clinical Scientific Expert Recruitment @ Novartis - Apply Online

Clinical Scientific Expert Recruitment @ Novartis – Apply Online

Dont forget to check out possible interview questions for this job below

Novartis hiring candidates with bachelor’s degree in pharma for the post of a Clinical Scientific Expert -I. D Pharma job opening, Pharma job opening 2023, Pharmacy job opening 2023, Novartis job opening 2023

Job Title: Clinical Scientific Expert -I

Job ID 363519BR

Eligbility Criteria:

• 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.

Job Description

“150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.”

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 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.

Interview Question & Answers for the above job role: 

  1. What experience do you have in clinical trial data review and analysis, and how have you contributed to ensuring high quality of clinical data?

Answer: I have over 3 years of experience in clinical trial data review and analysis, and I have worked on multiple studies across different disease areas. I have contributed to ensuring high quality of clinical data by performing patient level review and trends analysis, identifying clinical data insights, collaborating with relevant line functions to enhance the quality of clinical data review, and facilitating resolution of clinical data issues.

2. What is your understanding of Good Clinical Practice, and how have you applied it in your work?

Answer: Good Clinical Practice (GCP) is a set of ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. I have a fundamental knowledge of GCP and have applied it in my work by ensuring that protocol-level deviations, eligibility criteria, study assessments, and other aspects of the protocol are implemented consistently across the study.

3. How have you contributed to the development of study-level documents, including clinical sections of key regulatory documents?

Answer: I have contributed to the development of study-level documents by reviewing and writing clinical trial documents for study CSR activities and publications. I have also contributed to the development of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers, in collaboration with relevant line functions.

4. How have you handled conflicts or disagreements in your work, and what was the outcome?

Answer: I have handled conflicts or disagreements by collaborating across boundaries for shared success, resolving issues with minimal supervision, and understanding when to escalate. I have also used my negotiation and conflict resolution skills to resolve conflicts and disagreements. The outcome has been positive, with issues being resolved in a timely manner and with minimal impact on the study.

5. What kind of training materials have you produced and how have you provided training to iCTT?

Answer: I have produced training materials on various topics related to clinical trial data review and analysis, such as patient-level review, trends analysis, and data quality management. I have provided training to iCTT by conducting interactive training sessions, presenting training materials, and facilitating discussions to ensure that the team members have a clear understanding of the topics covered.

Apply Online

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