Clinical Study Support Head
Synthorx
About the job
Title: Clinical Study Support Head
Location: Hyderabad
The Clinical Study Support Head will lead and manage multiple teams within the R&D Hyderabad Hub, ensuring operational excellence in clinical trial support functions. This strategic leadership role will be responsible for directing, developing, and optimizing clinical study support operations while ensuring compliance with global standards and regulations. This role includes direct line management responsibilities, focusing on team training, coaching, motivation, and development. The ideal candidate will be an inspiring leader and change agent who drives innovation within the R&D Hub, leveraging digitalization and AI to enhance process efficiency.
Main responsibilities:
Strategic Leadership & Management: Lead and manage multiple team leaders and their associate team members from different R&D functions including Clinical Trial Support, TMF Record Management, Clinical Supply Chain Operations, and Early Trial Operations Support
Develop and implement strategic plans to build/develop/maintain the capability (in collaboration with respective R&D functions heads), enhance operational efficiency, and quality across all managed functions
Establish key performance indicators and monitor team performance to ensure delivery excellence
Build and maintain strong relationships with global R&D stakeholders and partners
Operational Excellence: Oversee clinical trial support operations, ensuring timely delivery of high-quality services
Direct Trial Master File (TMF) management activities, ensuring regulatory compliance and inspection readiness
Oversee clinical supply chain operations ensuring timely delivery of high-quality services to ensure on time delivery of clinical supplies at cost to clinical sites in support of Sanofi project portfolio progression
Supervise early trial operations support to facilitate seamless study execution
Team Development: Build, develop, and retain high-performing teams through effective leadership, coaching, and talent management
Build and foster a sense of community and team spirit.
Foster a culture of continuous improvement, innovation, and operational excellence
Implement training and development programs to enhance team capabilities and skills
Promote cross-functional collaboration and knowledge sharing
Quality & Compliance: Ensure adherence to global quality standards, SOPs, and regulatory requirements
Implement robust quality management systems across all managed functions
Prepare for and support regulatory inspections and audits
Drive process standardization and optimization initiatives
About you
Experience: Strong experience in clinical research operations with at least 5 years in leadership roles
Proven track record of managing multiple clinical operations teams
Experience with global clinical trials and understanding of international regulatory requirements
Soft Skills & Technical Skills: Strong leadership and people management skills with ability to motivate diverse teams
Excellent understanding of clinical trial processes, documentation, and regulatory requirements
Strategic thinking with ability to translate vision into actionable plans
Strong problem-solving skills and decision-making capabilities
Experience in process optimization and continuous improvement methodologies
Language: Excellent communication and stakeholder management skills; English fluency required.
Education: Advanced degree in Life Sciences, Pharmacy, or related field
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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