YOUR SKILLS AND EXPERIENCE

• Bachelor’s/Master’s degree in IT or a life science-related discipline with experience in IT, CRO, or Pharma.
• Excellent understanding of common industry-standard business practices related to clinical trials design and conduct including (study setup, clinical operations, data management, and reporting).
• Clinical & Regulatory Data Standards Expertise:
• Working knowledge of CDASH, SDTM, and CDISC controlled terminology in the context of clinical data and FHIR Electronic Health Records.
• Strong knowledge of ICH guidelines, 21 CFR Part 11, clinical trial methodology, and software development lifecycle activities.
• Experience with external vendors and CROs to support standards or EDC integrations with third-party platforms (e.g., Central Lab, ePRO, IRT, Data Review/Monitoring).
• Proven track record of successfully implementing eSource technologies, such as Electronic Data Capture (EDC) systems, IXRS, electronic Clinical Outcome Assessment (eCOA) platforms, and electronic Patient-Reported Outcome (ePRO) solutions.
• Technical Engineering & Full-Stack Development Expertise:
• Strong understanding of full-stack web application development, covering front-end, back-end, and database layers.
• Proficiency in modern front-end frameworks (e.g., React, Angular, or Vue.js) and back-end technologies (e.g., Node.js, Python, Java, or .NET).
• Experience in microservices architecture for scalable and modular applications, including API-driven development using RESTful and GraphQL services.
• Hands-on experience with cloud-based platforms (AWS, Azure, or GCP) for deploying and managing web applications.
• Understanding of containerization (Docker, Kubernetes) and DevOps practices (CI/CD, Infrastructure as Code).
• Experience in implementing data and content orchestration layers, ensuring seamless integration and interoperability between internal and external systems.
• Strong knowledge of API development, integration patterns, and security best practices (OAuth, JWT, OpenID Connect) for connecting with external applications and third-party platforms.
• Proficiency in programming languages (e.g., SQL, Python, JavaScript, Java) with a focus on data modeling, transformation, and analytics.
• Hands-on experience with data streaming and ETL pipelines using tools like Apache Kafka, Airflow, SnapLogic, MuleSoft or similar frameworks.
• Familiarity with NoSQL and relational databases (PostgreSQL, MongoDB, MySQL) for efficient data management and retrieval.
• Excellent communication skills, with the ability to collaborate effectively with stakeholders at all levels.
• Strong collaborative skills with a demonstrated ability to lead cross-functional teams and drive projects to successful completion.
• Experience in Agile development methodologies (Scrum, SAFe) for managing technology-driven projects in clinical and regulatory environments.
• Accredited Certifications from SCDM/ACDM or any vendor offered data management trainings.
• Experience with cloud-based platforms (e.g., Veeva, Salesforce, Oracle Clinical, AWS, Azure) and knowledge of security best practices in healthcare IT environments
• EDC build (Rave)/Inform and global library maintenance support experience a plus.
• Extensive Experience in clinical data management, clinical data analytics and visualization. clinical data programming experience is a plus

ENGINEERING, ALL FUELED BY ITS MARKET LEADING CAPABILITIES IN AI, GENERATIVE AI, CLOUD AND DATA, COMBINED WITH ITS DEEP INDUSTRY EXPERTISE AND PARTNER ECOSYSTEM. THE GROUP REPORTED 2024 GLOBAL REVENUES OF €22.1 BILLION.

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YOUR ROLE

• In this role one will have the opportunity to collaborate with Business Platform Manager, Product Manager/Owner, IT Platform Engineers, DevOps Lead, and Solution/Integration Architects within AZ to establish best practices for software development and engineering, business analysis, solution designs, enterprise software integration and project management in line with BizDevOps
• Responsibilities may include collaboration with Tech vendors and internal stakeholders to define technical requirements and develop functional and integration implementation plans around external clinical data acquisition into EDC or Data Management Review application such as Veeva, Medidata or Signant
• Serve as Technical Subject Matter Expert (SME) for Clinical Data acquisition solutions through the implementation process and life cycle of the study by providing guidance to the partner/sponsor and internal teams on the design and support of Clinical Data Products.
• Coordinate technical backlogs/Story/Epic in JIRA (as appropriate) and ensure IT delivery based on the product delivery roadmap priority in Agile WoWs.”