Senior Study Data Manager in Hyderabad, India - Join Sanofi!

Are you ready to take on a leading role in Clinical Data Management? As a Senior Study Data Manager at Sanofi, you'll be instrumental in guiding end-to-end CDM activities within our Clinical Trial Team (CTT), ensuring study deliverables are met from set-up through to close-out with adherence to GCP and regulatory guidelines.

About the Role

Your role will be pivotal in transforming our healthcare innovations. As part of our dynamic team, you'll drive performance and reliability of clinical study data, ensuring accurate and robust study results. Your expertise will help coordinate global cross-functional data activities, ensuring high-quality standards and timely completion of tasks.

Key Responsibilities

• Accountable for the quality of CDM deliverables, including CRFs, Data Management Plans, and Data Validation Specifications.
• Coordinate all CDM activities globally with internal stakeholders like the Global Study Manager and Statistician.
• Identify and resolve CDM issues proactively throughout the study's lifecycle.
• Define and execute data cleaning and validation strategies.
• Contribute to protocol reviews, data reviews, and SAE reconciliations.
• Lead study activities with both internal and external CDM teams, mentoring new managers.
• Manage external data specifications and reconciliation, including data from Central Labs and telemedicine.

About You

We are looking for someone with extensive experience in clinical data management and a proven track record in project management. Strong interpersonal, communication, and presentation skills are essential. You should have a solid understanding of CDM regulations, Quality by Design (QbD) principles, and advanced drug development concepts like Decentralized Clinical Trials (DCT) and AI-based automation.

Qualifications

• Bachelor’s degree or above, preferably in a life science or drug development field.
• Strong proficiency in English, both verbal and written.
• Experience with CDM, ICH E6 and E8 regulations.

Why Join Sanofi?

Join a team dedicated to bringing scientific miracles to life and transforming healthcare. You’ll find endless opportunities to grow and advance your career at Sanofi. Our comprehensive rewards package is designed to recognize your contributions and amplify your impact.

Benefits

• Opportunities for career advancement and development.
• Involvement in cutting-edge clinical data management innovations.
• A supportive, future-focused team environment.
• Diverse and inclusive workplace.

At Sanofi, we believe in providing equal opportunities to all, regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.

Join Us and Pursue Progress

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people. Let’s be those people who make miracles happen.

Interested? Watch our ALL IN video and learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com!

Sanofi is at the forefront of Clinical Data Management Modernization. Join us and help transform our vision into reality!

Company: Sanofi

Job Title: Senior Study Data Manager