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Clinical Scientific Expert I

2+ years
Not Disclosed
10 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Clinical Scientific Expert I – Hyderabad, India
Innovative Medicines, Research & Development

About Novartis
At Novartis, our purpose is to reimagine medicine and improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company in the world, driven by our people who are dedicated to achieving this mission. Join us in making a meaningful impact on global healthcare.

Role Overview
We are seeking a Clinical Scientific Expert I (CSE I) to join our Clinical Trial Team (CTT) in Hyderabad. The CSE I will provide clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D. You will play an essential role in ensuring the quality and integrity of clinical trial data and identifying key clinical data insights, trends, and risks related to trial endpoints and patient safety.

Key Responsibilities

  • Perform high-quality clinical data review and analysis, identifying insights through patient-level review and trends analysis. Support interim analysis, database activities, and post-lock tasks.
  • Contribute to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy. Ensure consistent implementation of protocol deviations, eligibility criteria, study assessments, and other protocol aspects.
  • Collaborate with relevant line functions to enhance clinical data quality with a focus on subject safety, data integrity, and trend identification.
  • Contribute to the development of study-level documents, including Investigator’s Brochures, safety updates, and submission dossiers.
  • Support pharmacovigilance activities as required, including reviewing aggregate reports and attending Safety Monitoring Meetings (SMT).
  • Develop training materials and provide training to the Integrated Clinical Trial Team (iCTT).
  • Facilitate data review process improvements, identifying issues such as delinquent/redundant reports and implementing innovative data analysis processes and tools.

Minimum Requirements

  • Advanced degree in life sciences or a clinically relevant field (e.g., Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD).
  • At least 1 year of experience in pharmaceutical industry or clinical research organization.
  • Basic knowledge of planning, executing, reporting, and publishing global clinical studies.
  • Strong interpersonal, negotiation, and conflict resolution skills.
  • Familiarity with Good Clinical Practice (GCP), clinical trial design, statistics, and regulatory processes.
  • Strong analytical and computational skills with the ability to identify trends and interpret clinical data.
  • Demonstrates strong medical and scientific writing skills.

Why Novartis?
At Novartis, we are committed to building an inclusive and collaborative work environment. We believe that achieving breakthroughs requires the collective effort of passionate individuals like you. Join us in our mission to reimagine medicine and improve lives globally.

Join Our Novartis Network
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Benefits and Rewards
Explore our Novartis Life Handbook to learn more about our benefits and rewards program.

Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. Please email diversityandincl.india@novartis.com for assistance.