Your key responsibilities
- Design and implement integration solutions to connect Medidata clinical trial systems with other applications within the clinical data landscape.
- Develop and configure system interfaces using programming languages (e.g., Java, Python, C#) or integration middleware tools (e.g., Informatica, AWS, Apache NiFi).
- Collaborate with clinical business stakeholders and IT teams to gather requirements, define technical specifications, and ensure interoperability.
- Create and maintain integration workflows and data mappings that align with clinical trial data standards (e.g., CDISC, SDTM, ADaM).
- Ensure all development and implementation activities comply with GxP regulations and are aligned with validation best practices.
- Participate in agile development processes, including sprint planning, code reviews, testing, and deployment.
- Troubleshoot and resolve integration-related issues, ensuring stable and accurate data flow across systems.
- Document integration designs, workflows, and technical procedures to support long-term maintainability.
- Contribute to team knowledge sharing and continuous improvement initiatives within the integration space.
Skills and attributes for success
- Apply a hands-on, solution-driven approach to implement integration workflows using code or middleware tools within clinical data environments.
- Strong communication and problem-solving skills with the ability to collaborate effectively with both technical and clinical teams.
- Ability to understand and apply clinical data standards and validation requirements when developing system integrations.
To qualify for the role, you must have
- Experience: Minimum 5 years in software development within the life sciences domain, preferably in clinical trial management systems.
- Education: Must be a graduate preferrable BE/B.Tech/BCA/Bsc IT
- Technical Skills: Proficiency in programming languages such as Java, Python, or C#, and experience with integration middleware like Informatica, AWS, or Apache NiFi; strong background in API-based system integration.
- Domain Knowledge: Solid understanding of clinical trial data standards (e.g., CDISC, SDTM, ADaM) and data management processes; experience with agile methodologies and GxP-compliant development environments.
- Soft Skills: Strong problem-solving abilities, clear communication, and the ability to work collaboratively with clinical and technical stakeholders.
- Additional Attributes: Capable of implementing integration workflows and mappings, with attention to detail and a focus on delivering compliant and scalable solutions.
Ideally, you’ll also have
- Hands-on experience with ETL tools and clinical data pipeline orchestration frameworks relevant to clinical research.
- Hands-on experience with clinical R&D platforms such as Oracle Clinical, Medidata RAVE, or other EDC systems.
- Proven experience leading small integration teams and engaging with cross-functional stakeholders in regulated (GxP) environments.
What we look for
- A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment
- An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
- Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries