Clinical Study Support Head
Sanofi Group
**_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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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