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Clinical Scientific Expert - I

3-5 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Job Title: Clinical Scientific Expert I (CSE I)
Company: Novartis Healthcare Private Limited, Hyderabad, India
Job Type: Full-Time | Experienced | Onsite
Job ID: REQ-10060761
Application Date: 02/11/2025

About Novartis:
Novartis is a global healthcare leader committed to improving and extending people’s lives through innovative medicines. With a focus on research and development across diverse therapeutic areas, Novartis combines cutting-edge science, advanced technology, and a patient-centric approach to deliver breakthrough treatments worldwide. The organization promotes an inclusive, collaborative, and high-performance work culture that values innovation, integrity, and teamwork.

Role Overview:
Novartis is seeking a Clinical Scientific Expert I (CSE I) to provide clinical and scientific support across all phases of global clinical trials. Reporting to the (A)CD(M)D, the CSE I ensures clinical data integrity, identifies trends, signals, and risks, and contributes to trial outcomes within timelines, budget, and quality standards. The CSE I is a core member of the Clinical Trial Team (CTT) and may also support program-level activities as assigned.

Key Responsibilities:

  • Execute assigned clinical trial activities efficiently, ensuring compliance with Novartis processes, ICH GCP, and regulatory requirements.

  • Perform high-quality clinical data reviews, identify data insights, and ensure scientific plausibility of trial outcomes.

  • Support program-level tasks such as tracking study milestones and operational risk management.

  • Manage interactions with internal stakeholders including Data Management, Clinical Development, Drug Supply, and Country Pharma teams.

  • Report technical complaints, adverse events, and special case scenarios within 24 hours of receipt.

  • Contribute to study documents, including protocols, informed consent forms (ICF), and clinical sections of CTA submissions.

  • Apply proactive operational planning with contingency and risk mitigation strategies.

  • Ensure all activities adhere to Novartis values: Innovation, Quality, Collaboration, Performance, Courage, and Integrity.

Experience & Qualifications Required:

  • Minimum 3–5 years of experience in clinical research or clinical trial execution.

  • Experience in cross-cultural environments, operations management, and project execution.

  • Strong understanding of clinical trial protocols, regulatory compliance, and data integrity standards.

  • Proven ability to collaborate effectively across functions and geographic boundaries.

  • Proficiency in English, with excellent written and verbal communication skills.

Skills & Competencies:

  • Clinical trial design and execution

  • Risk monitoring and trend analysis

  • Clinical data review and insights generation

  • Learning design and team knowledge sharing

  • Strong organizational, analytical, and problem-solving skills

Why Join Novartis:

  • Contribute to global clinical research that improves patients’ lives.

  • Collaborate with a community of experts across multiple therapeutic areas.

  • Access to comprehensive learning and development opportunities.

  • Thrive in an inclusive, diverse, and flexible work environment.

  • Competitive remuneration and benefits aligned with performance and career growth.

Location:
Novartis Healthcare Private Limited, Hyderabad, India

Equal Employment Opportunity:
Novartis is committed to building an inclusive, diverse work environment. The company provides reasonable accommodations for individuals with disabilities and ensures equal opportunities for all candidates, irrespective of legally protected characteristics.

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