Clinical Scientific Expert I

1+ years

Not Disclosed

India Remote

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: PharmD/M.Pharma/PhD/MBBS/BDS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Scientific Expert I (CSE I)
Company: Novartis
Location: Hyderabad, India (Office-Based)
Division: Development
Functional Area: Research & Development
Employment Type: Full-time, Regular

About the Role

As a Clinical Scientific Expert I (CSE I), you will provide clinical and scientific support through all phases of a clinical study. Under the guidance of the (A)CD(M)D, you will ensure adherence to Novartis processes, ICH GCP, and regulatory requirements. You will work closely with the Clinical Trial Team (CTT) to review clinical data, identify trends, signals, and risks, and ensure data integrity, patient safety, and eligibility.

Key Responsibilities

Clinical Data Review: Conduct high-quality clinical data reviews and identify insights through patient-level analysis and trend detection. Support interim analysis, database activities, and post-lock activities.
Data Strategy: Develop and implement the Data Review/Quality Plan (DRP/DQP), ensuring protocol-level deviations and eligibility criteria are consistently followed across the study.
Collaborative Activities: Work with relevant functions to improve data review processes and enhance data integrity. Support the development of Case Report Forms (CRFs) and data capture tools.
Documentation and Regulatory Support: Contribute to key regulatory documents, including Investigator’s Brochures, safety updates, submission dossiers, and clinical trial documents.
Pharmacovigilance Support: May contribute to pharmacovigilance activities, such as reviewing aggregate reports and patient narratives.
Training & Support: Develop training materials and provide training to the Integrated Clinical Trial Team (iCTT).

Qualifications

Education: Advanced degree in life sciences/healthcare (e.g., Master's, PharmD, PhD, MBBS, MD) is strongly preferred.
Experience: At least 1 year of experience in the pharmaceutical industry or clinical research, with a basic understanding of clinical study planning, execution, reporting, and publishing.
Skills:
- Strong analytical and computational background.
- Knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, and regulatory processes.
- Excellent medical/scientific writing skills.
- Ability to identify trends, analyze, interpret, and report clinical data.
- Strong interpersonal, negotiation, and conflict resolution skills.

Why Novartis?

At Novartis, our mission is to reimagine medicine to improve and extend people’s lives. We believe that with our people, we can achieve this vision. Join us and contribute to meaningful change by working alongside passionate and driven colleagues.

Commitment to Diversity & Inclusion

Novartis is committed to creating an inclusive work environment that values diversity and representation, ensuring that all employees have the opportunity to thrive.

Benefits and Rewards

Novartis offers a comprehensive benefits package designed to help you grow both personally and professionally. Learn more about our rewards and benefits here.

For more information about this opportunity or to apply, please visit the Novartis Careers page.

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Clinical Scientific Expert I

Job Description

About the Role

Key Responsibilities

Qualifications

Why Novartis?

Commitment to Diversity & Inclusion

Benefits and Rewards

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