Job Description

About the job
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Title:

Clinical Study Support Head

Location:

Hyderabad

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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:

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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
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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

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