Title: Senior Study Leader
Company: Novartis
Location: India
Job ID: REQ-10050471
Posted Date: April 28, 2025
Work Type: Full-time
Function: Clinical Operations
Industry: Pharmaceuticals / Life Sciences
Job Summary:
The Senior Study Leader is responsible for the successful execution and delivery of clinical studies of standard to medium complexity within Global Clinical Operations (GCO). Working in tandem with the Clinical Science Lead (CSL), the role involves leading cross-functional clinical trial teams (CTTs), managing operational plans, timelines, and budgets, and ensuring delivery against quality and compliance standards. The role promotes operational excellence, proactive risk management, and fosters cross-functional collaboration.
Key Responsibilities:
Co-lead the clinical trial team (CTT) in planning, executing, and delivering global clinical studies per protocol and execution plans
Act as product owner for the CTT, overseeing operational strategy and ensuring sprint-based agile execution
Drive development of high-quality protocols and study documents in collaboration with clinical and regulatory teams
Establish and manage study timelines, budgets, recruitment goals, and vendor relationships
Embed risk management practices and ensure inspection readiness across all study activities
Maintain up-to-date systems and documentation, including Trial Master File
Build effective team dynamics, guide prioritization, and align with global and local teams
Represent study operations in internal meetings, contributing to strategic decision-making
Lead or support process improvement initiatives and cross-study knowledge sharing
Minimum Requirements:
≥ 4 years of experience in clinical research or drug development (Phases I–IV)
≥ 3 years of experience delivering end-to-end clinical studies in global or matrix environments
Strong knowledge of GCP, ICH, FDA, EMA, and local regulatory standards
Prior experience managing virtual or cross-cultural teams preferred
Excellent project management, communication, organizational, and conflict resolution skills
Proven leadership capabilities with ability to work in complex, dynamic environments
Key Competencies:
Clinical Study Management
Cross-Functional Leadership
GCP & Regulatory Compliance
Operational Excellence & Risk Management
Agile Methodologies
Budget and Timeline Oversight
Stakeholder and Vendor Collaboration
Why Join Novartis:
Join a purpose-driven organization focused on reimagining medicine and changing patients’ lives. Novartis fosters collaboration, growth, and innovation through its global network and diverse teams.
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