Join Our Team as a Principal Study Data Manager in Hyderabad, India

Are you ready to transform your career and make a global impact? At Sanofi, we invite you to take the lead in Clinical Data Management as our Principal Study Data Manager in Hyderabad, India. This pivotal role involves spearheading end-to-end Clinical Data Management activities within our Clinical Trial Team (CTT), ensuring adherence to GCP and regulatory guidelines.

At Sanofi, our innovation hubs are the driving force behind our success, enhancing performance across every department and supporting groundbreaking work that changes millions of lives. Embrace this opportunity to advance your career and contribute to our transformative projects.

Key Responsibilities

As the Principal Study Data Manager, your core responsibilities will include:

• Ensuring the quality and accuracy of CDM deliverables, including CRFs, Data Management Plans, and Data Validation Specifications.
• Coordinating CDM activities with internal stakeholders such as Global Study Managers, Statisticians, and Pharmacovigilance teams.
• Proactively identifying and resolving CDM issues throughout the study's conduct.
• Implementing risk-based data cleaning and validation strategies.
• Participating in protocol reviews and various study oversight activities.
• Leading internal and external CDM delivery teams and mentoring new Study Data Managers.
• Managing external data activities, including data from Central Labs, eCOA, and mobile healthcare technologies.
• Driving continuous improvement initiatives and leading transformation projects.

About You

To excel in this role, you should possess:

• Experience: Extensive clinical data management experience with a history of project management roles.
• Soft Skills: Strong project management capabilities, risk assessment, and excellent interpersonal communication skills.
• Technical Skills: Profound knowledge of CDM and regulatory requirements, with a focus on Quality by Design (QbD) and risk-based methodologies.
• Education: Bachelor’s degree or higher, preferably in life sciences or a related field.
• Languages: Proficiency in English, both verbal and written, with the ability to communicate effectively in a global environment.

Why Choose Sanofi?

Sanofi stands at the forefront of Clinical Data Management Modernization. Join us to:

• Bring scientific miracles to life alongside a forward-thinking, supportive team.
• Explore boundless opportunities to grow and advance your career, whether locally or internationally.
• Receive a thoughtfully designed rewards package that acknowledges your contributions.
• Be part of an international, innovative biopharma company ushering in new advancements in Clinical Data Management.

"Sanofi is at the forefront of Clinical Data Management Modernization. Our ambitions are significant but pragmatic. The speed of change is unprecedented but achievable. Join us if you want to help us transform our vision into a reality!"

Pursue Progress, Discover the Extraordinary

Progress is fueled by people—those who are diverse, from different backgrounds, and with varied roles—all united in the quest to make miracles happen. At Sanofi, we champion equal opportunities for all, regardless of your background or identity.

Watch our ALL IN video and explore our Diversity, Equity, and Inclusion initiatives at sanofi.com!

Additional Information

Company Name: Sanofi

Job Title: Principal Study Data Manager