Clinical Study Support Head – Hyderabad, India
Experience Required: Minimum 5 years in clinical research operations with leadership experience
About the Company
Sanofi is a global biopharmaceutical leader dedicated to advancing healthcare innovation across oncology, rare diseases, neurology, and vaccines. By integrating deep scientific expertise with AI-driven discovery, Sanofi transforms breakthrough ideas into tangible patient impact worldwide. The Hyderabad R&D Hub serves as a center of excellence for clinical research, early trial operations, and clinical study support. Learn more at www.sanofi.com.
Role Overview
The Clinical Study Support Head will provide strategic and operational leadership for multiple teams within Sanofi’s Hyderabad R&D Hub. The role ensures operational excellence in clinical trial support functions, including Trial Master File (TMF) management, clinical supply chain, and early trial operations. This position involves line management responsibilities, team development, process optimization, and digital transformation initiatives using AI and data-driven solutions.
Key Responsibilities
Strategic Leadership & Management:
Lead multiple teams across clinical trial support, TMF record management, clinical supply chain, and early trial operations.
Develop and implement strategic plans to enhance team capability, efficiency, and quality.
Establish key performance indicators (KPIs) and monitor team performance to ensure delivery excellence.
Build strong relationships with global R&D stakeholders and cross-functional partners.
Operational Excellence:
Oversee clinical trial support operations to ensure high-quality and timely delivery of services.
Direct TMF management activities, ensuring regulatory compliance and inspection readiness.
Manage clinical supply chain operations for timely and cost-effective delivery of clinical materials.
Supervise early trial operations to enable seamless study execution.
Team Development & Culture:
Build, develop, and retain high-performing teams through coaching, mentoring, and talent management.
Foster a culture of continuous improvement, innovation, and collaboration.
Implement training and development programs to enhance team skills and capabilities.
Quality & Compliance:
Ensure adherence to global quality standards, SOPs, and regulatory requirements.
Implement and maintain robust quality management systems across all managed functions.
Support regulatory inspections and audits with accurate documentation and readiness.
Drive process standardization and optimization initiatives to enhance operational efficiency.
Candidate Profile
Experience & Qualifications:
Minimum 5 years of leadership experience in clinical research operations.
Proven track record of managing multiple clinical operations teams.
Experience with global clinical trials and knowledge of international regulatory requirements.
Advanced degree in Life Sciences, Pharmacy, or related field.
Skills & Competencies:
Strong leadership, people management, and team-building abilities.
In-depth understanding of clinical trial processes, documentation, and compliance standards.
Strategic thinking with the ability to translate vision into actionable plans.
Excellent problem-solving, decision-making, and stakeholder management skills.
Experience in process optimization and continuous improvement methodologies.
Fluency in English, with excellent verbal and written communication skills.
Why Join Sanofi
Sanofi invests in its people to think faster, grow further, and achieve what has never been done before. You will have opportunities to:
Lead high-impact teams and influence clinical research operations globally.
Drive digitalization and AI integration in clinical trial support.
Contribute to transformative scientific advancements that improve patient lives.
Grow your career in a culture of inclusion, diversity, and continuous learning.
Sanofi is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, ancestry, religion, sex, national origin, sexual orientation, age, disability, gender identity, protected veteran status, or other legally protected characteristics.
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