Job Description

Job title: Study Data Lead Early DevelopmentLocation: IN / HyderabadAbout the jobOur Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Study Data Lead Early Dev within our Clinical Data Management, You\xe2\x80\x99ll lead a regionally based CDM team ensuring that the data management activities assigned to his/her team are completed according to agreed standards at global, TA and Product Level, timelines, and quality/performance targets.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people\xe2\x80\x99s lives. We\xe2\x80\x99re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Main responsibilities:People: (1) Managing a team of Clinical Data Management Actors (Study Data Managers and/or Clinical Data Coordinator, any other relevant role), including performance review and development dialogue. (2) Ensuring the training, mentoring, engagement, development, and recognition of his/her team members to maximizing their potential, performance, and overall success.Performance and Delivery: (1) Acting as the Data Management point of accountability for the execution of data management activities for specific clinical studies / programs assigned to his/her team. (2) Assisting the CDM TA Head with resource optimization based on the portfolio risk adjustments, team member competencies, and core project milestones. (3) Driving and supporting his/her team planning and delivering strong study execution operational plans based on best data management practices and robust risk management strategies.Process: (1) Ensuring operational consistency, alignment and identifying synergies across assigned studies and programs. (2) Participating in global harmonization and optimization of operational processes and standards and fosters innovation and continuous improvement.Stakeholder: (1) Work closely with global Study Teams. (2) Maintain effective relationship with Global Clinical Data Management.About youExperience: Experience with CDM and related regulations (incl. ICH E6 and E8).Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations.Effective leadership and people management skills. Harness a working environment which encourages teamwork, energy, and creativity.Soft and technical skills: Solid risk-based mindset focusing on Quality by Design (QbD) and on what really matters.Learn and adapt quickly when facing new problems.Think critically and use rigorous, objective, and pragmatic methods to solve multidimensional problems with effective and timely solutions.Strong project management skills and experience.Anticipate delivery risks, bottlenecks, issues, and delays to proactively prevent them or minimize their impact.Education: Advanced degree, preferably in a life science or drug development related field.Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.Why choose us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it\xe2\x80\x99s through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Join an international innovative biopharma company.Participate in the evolution of Clinical Data Management and deployment of innovations.\xe2\x80\x9cSanofi is at the forefront of the Clinical Data Management Modernization. Our ambitions are significant but pragmatic. The speed of change unprecedented but achievable. Join us of you want to help us transform our vision into a reality!\xe2\x80\x9dPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s 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 and check out our Diversity Equity and Inclusion actions at !

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