Integration - Clinical Platform - Medidata

Medidata Rave

Location:Pune
Experience: 6yrs – 9yrs

Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading healthcare and life sciences organizations deliver clinical trials efficiently and compliantly across the globe.

Your Role

As a Clinical Database Designer/eCRF Specialist at Capgemini, you will design and maintain clinical study databases that ensure accurate data collection and compliance with global standards. You’ll work independently and collaborate with cross-functional teams to deliver robust technical solutions for complex trials.

In this role, you will:

• Design study databases and eCRFs per protocol in Medidata Rave, implementing dynamic features and edit checks for data collection and cleaning.
• Maintain clinical databases post-production, including impact assessments and migrations.
• Develop and update study setup Gantt charts to align with timelines and track data management tasks.
• Configure customer-specific solutions integrated with clinical data systems (e.g., Safety-to-RAVE interface).
• Request new database models or updates from the Clinical Information Governance team.
• Manage technical documentation (user guides, specifications, best practices, programming conventions).
• Analyze new customer requirements and propose technical solutions.

Your Profile

• Education: Bachelor’s or Master’s degree in Life Sciences, Mathematics, Computer Science, or related fields.
• Experience:
  • Proven expertise in clinical database design and maintenance for complex trials.
  • Clinical trial and data management experience preferred.
  • Pharmaceutical industry exposure is a plus.
• Technical Skills:
  • Advanced knowledge of Medidata Rave and clinical data management systems.
  • Strong understanding of database structures and administration.
  • Proficiency in C# programming and SQL.
  • Familiarity with CDISC standards (CDASH, SDTM).
  • Knowledge of regulatory guidelines and GCP practices.
• Additional Skills:
  • Advanced project management and collaboration skills.
  • Strong analytical and problem-solving abilities.
  • Excellent communication and meeting management skills.
  • Understanding of modern clinical trial concepts (DCT, adaptive protocols, eSource, AI-based automation) is a plus.
• Language: Fluent English (verbal and written) for global communication.

What You’ll Love About Working Here

We value flexibility and support our employees with remote work options and adaptable schedules to maintain a healthy work-life balance. Our inclusive culture brings together diverse professionals committed to growth, innovation, and excellence. You’ll have access to continuous learning opportunities and certifications in emerging technologies and methodologies.

About Capgemini

Capgemini is a global business and technology transformation partner, helping organizations accelerate their dual transformation to address the evolving needs of customers and citizens. With a strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs—from strategy and design to operations.