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Integration - Clinical Platform - Medidata

Integration - Clinical Platform - Medidata

Capgemini

6 - 11 years

9 - 13 Lacs

pune

Posted:21 hours ago| Platform:

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Skills Required

compliance project management data management ai data collection sql healthcare database design automation gcp software solutions software engineer software engineering clinical trials life sciences clinical data systems programming

Work Mode

Work from Office

Job Type

Full Time

Job Description

About The Role
Medidata Rave
Location: Pune
Experience: 6yrs 9yrs
Choosing Capgemini means choosing a place where youll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine whats 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. Youll 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: Bachelors or Masters 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.

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Integration - Clinical Platform - Medidata