Job
Description
Role Overview: As a Clinical Database Designer/eCRF Specialist at Capgemini, you will be responsible for designing and maintaining clinical study databases to ensure accurate data collection and compliance with global standards. Working independently and collaborating with cross-functional teams, you will deliver robust technical solutions for complex trials. Your role will involve designing study databases and eCRFs per protocol in Medidata Rave, maintaining clinical databases post-production, developing and updating study setup Gantt charts, configuring customer-specific solutions, managing technical documentation, and analyzing customer requirements to propose technical solutions. Key Responsibilities: - 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 Qualifications Required: - 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 Additional Details: Capgemini values flexibility and supports employees with remote work options and adaptable schedules to maintain a healthy work-life balance. The inclusive culture at Capgemini brings together diverse professionals committed to growth, innovation, and excellence. Continuous learning opportunities and certifications in emerging technologies and methodologies are accessible to employees. (Note: The additional details about Capgemini's global business and technology transformation partnership have been omitted as they are not directly related to the job role described.) Role Overview: As a Clinical Database Designer/eCRF Specialist at Capgemini, you will be responsible for designing and maintaining clinical study databases to ensure accurate data collection and compliance with global standards. Working independently and collaborating with cross-functional teams, you will deliver robust technical solutions for complex trials. Your role will involve designing study databases and eCRFs per protocol in Medidata Rave, maintaining clinical databases post-production, developing and updating study setup Gantt charts, configuring customer-specific solutions, managing technical documentation, and analyzing customer requirements to propose technical solutions. Key Responsibilities: - 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 Qualifications Required: - 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 (CDA
