Senior Database Designer (Rave Clinical Programmer + Custom Function)

Job title: Senior Database Designer (Rave Clinical Programmer + Custom Functions)

• Location: Hyderabad, India

About the job

Our 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. Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives. Ready?  As Senior Database Designer within our Hyderabad Hub, you’ll be responsible for developing and implementing database elements (structure, data entry screens, edit checks) and setting-up peripheral tools interfaced with our clinical data management system (e.g., Safety Gateway). You will ensure that any study databases are set up and maintained according to defined timelines and standards to support a flawless conduct of clinical trials. You are the expert for clinical study database, eCRF and standards.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re 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:

• Designing study database/eCRF per protocol and implementing dynamism and edit check programming per data collection and cleaning needs in Medidata Rave

• Ensuring clinical database post-production maintenance including impact assessment analysis and database migration

• Developing, reviewing and updating the study setup Gantt Chart to comply with study timeline, and following-up the data management related tasks accordingly

• Configuring Sanofi specific solutions interfaced with the clinical data management systems (e.g., Safety to RAVE interface)

• Requesting new database models or updates to the Clinical Information Governance team

• Managing the technical writing at study team level (i.e., user guides, detailed specifications, best practices, programming conventions, etc.)

• Analyzing new requirements from customer and propose technical solution strategies

About you

• Experience: Experience in clinical database design and maintenance are required and he/she can lead database design and maintenance for complex trials independently.

• In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred.

• Soft and technical skills: Advanced project management skill

• Advanced collaboration and communication skill

• Outstanding capability of independent thinking and delivery of accurate outcomes

• Meeting management skill such as organize meeting and discussion

• Crystal clear logical thinking

• Advanced expertise in Clinical Data Management Systems (e.g. Medidata Rave, etc.)

• Advanced expertise in database structure and database administration

• Advanced expertise in C# programming and query language such as SQL.

• Knowledge of industry standards and practices (e.g. CDISC especially CDASH and SDTM)

• Strong knowledge of current regulatory guidelines, and GCP practices regarding Data Management

• Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus

• Education: Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e.g., Pharmaceutical, medical, or mathematics, computer science or similar technical fields).

• 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’s 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.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Join an international innovative biopharma company.

• Lead clinical database setup and maintenance and act as an expert working on several therapeutic areas.

• Participate in the evolution of Clinical Data Management and deployment of innovations

“As a Senior database designer in our India Hub, you’ll get the opportunity to lead clinical database setup for global studies in different therapeutic areas and act as the study database expert to develop your career in the global organization. Join the Best, Be the Best!”