Senior Product Software Engineer - Clinical IT Product Tech Lead

About the job you’re considering

As a eConsent Product Tech Lead, you will be key member of the Clinical Development Platform capability IT team managing Clinical eSource technologies and solutions such as EHR, eCOA/ePRO, Labs built on products such as EDC, IXRS to ensure data is capture, transform, and publish in adherence to CDISC standards and risk-based study monitoring approach. 

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."

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

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55 year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to

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.

Get the future you want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.

Capgemini discloses salary range information in compliance with state and local pay transparency obligations. The disclosed range represents the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting, although we may ultimately pay more or less than the disclosed range, and the range may be modified in the future. The disclosed range takes into account the wide range of factors that are considered in making compensation decisions including, but not limited to, geographic location, relevant education, qualifications, certifications, experience, skills, seniority, performance, sales or revenue-based metrics, and business or organizational needs. At Capgemini, it is not typical for an individual to be hired at or near the top of the range for their role. The base salary range for the tagged location is [$86,900 - $149,240]. This role may be eligible for other compensation including variable compensation, bonus, or commission. Full time regular employees are eligible for paid time off, medical/dental/vision insurance, 401(k), and any other benefits to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, or any other form of compensation that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.