Clinical Scientific Expert Ii

0-2 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

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

Job Title: Clinical Scientific Expert II
Location: India (Hyderabad, Office)
Job ID: REQ-10038355
Date Posted: Feb 04, 2025
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-Time, Regular
Shift Work: No

Job Purpose

The Clinical Scientific Expert II (CSE II) contributes to all relevant aspects of global clinical trial activities, ensuring that study outcomes are achieved within the set timelines, budgets, and performance standards. The CSE II is a key member of the Clinical Trial Team (CTT), providing clinical and scientific support throughout the various phases of a clinical study. This role ensures clinical data review excellence and identifies insights to ensure data integrity, trends, signals, and risks are addressed, in compliance with regulatory requirements and Novartis processes.

Key Responsibilities

Clinical Trial Management & Execution

Contribute to the planning and execution of clinical trials, ensuring deliverables are met according to timelines, budgets, and quality/compliance standards.
Oversee study start-up activities including protocol development, CRF development, and Informed Consent Form development.
Manage the study conduct and close-out activities, including site close-out, final drug accountability, and ensuring the Trial Master File (TMF) is audit-ready.

Clinical Data Review & Insights

Perform clinical data reviews and provide insights to ensure scientific plausibility and data accuracy.
Identify trends, signals, and risks associated with trial endpoints and patient safety.
Ensure clinical data review activities comply with Novartis quality standards, timelines, and are inspection-ready.

Documentation & Compliance

Contribute to the preparation of study/program level documents, including study protocols, informed consent forms, clinical sections of Clinical Trial Agreements (CTA), and submission documents.
Ensure adherence to Novartis SOPs, best practices, and regulatory standards, sharing lessons learned and contributing to continuous improvement.

Leadership & Collaboration

Lead and contribute to local and global initiatives, focusing on competency building and sharing best practices across programs and departments.
Foster collaboration and share lessons learned to improve clinical trial execution across teams.

Key Performance Indicators

Timely and efficient execution of assigned trials, meeting budget and quality standards.
Proactive operational planning with effective risk mitigation strategies.
High-quality contributions to study/program level documents and clinical data review.
Clear demonstration of Novartis values and behaviors (Innovation, Quality, Collaboration, Performance, Courage, and Integrity).

Minimum Requirements

Work Experience

Experience in Clinical Research, Clinical Trial Protocol development, and Clinical Trials management.
Strong skills in Project Management, Budget Management, and Risk Monitoring.
Experience in Data Analysis, Data Integrity, and Trends Analysis.
Ability to Collaborate Across Boundaries and contribute to Operations Management and Execution.

Skills

Expertise in Clinical Research, Clinical Trial Protocols, and Risk Monitoring.
Ability to Coach and facilitate Learning Design in clinical operations.
Proficiency in Budget Management and Data Integrity.

Languages

Proficiency in English.

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