Systems Lead, Data Analyst, IT​/Tech

Location: Greater London

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** WHAT -*
* ** Summary & Purpose of the Position
**** WHAT -*
* ** Main Responsibilities & Technical Competencies
*** Maintain expert knowledge of Ipsen’s regulated clinical and analytical systems landscape, including statistical computing environments (SCE), GxP‑compliant data repositories, electronic data capture (EDC) platforms, interactive response technologies (IRT/RTSM), clinical data integration and analytics solutions, and data standards compliance tools, as well as emerging market solutions.
* Proactively assess system capabilities and limitations to recommend optimisations, replacements, or new solutions aligned with business, regulatory, and data strategy needs.
* Engage with business users and SMEs to gather, analyse, and document user requirements for new systems, enhancements, or replacements.
* Actively participate in RFP activities, including requirements definition, vendor evaluation, and selection, notably for the ongoing RTSM and forecasting system review and future implementation.
* Ensure continuous maintenance of the validated state of all GxP-relevant systems, including but not limited to including SCE, GxP‑compliant data repositories, EDC platforms, IRT/RTSM, clinical data integration and analytics solutions, in accordance with Ipsen SOPs and applicable regulatory requirements.
* Coordinate validation activities for system implementations, upgrades, patches, and expansions, including:  + Validation planning and timeline tracking  + Development, execution, and review of UAT and validation documentation (Validation Plans and Summaries, UAT scripts, validation packages).
* Work closely with IT and Quality Assurance to ensure systems remain inspection-ready and in a constant state of compliance with periodic reviews.
* Monitor regulatory and industry developments impacting data integrity, electronic records, and validated systems.
* Act as the primary business support contact for users of biometric systems.
* Manage all user access requests (internal and external), ensuring appropriate role-based access and compliance with governance requirements.
* Deliver system training sessions and maintain training records, user guides, and supporting documentation.
* Develop, update, and maintain training materials and e-learning content to support system adoption and correct use.
* Collect user feedback on system usability and training effectiveness and coordinate updates as required.
* Monitor user requests, support tickets, and usage patterns to identify trends, recurring issues, or training gaps.
* Propose targeted training initiatives, process improvements, or system enhancements to address recurring needs.
* Author and update system-related SOPs and process documentation as required.
* Recommend system and documentation improvements to improve efficiency, compliance, and user experience.
* Maintain awareness of internal and external changes impacting system usage and business processes.
* Clearly defines ownership and accountability for outcomes.
* Encourages clarification when responsibilities are unclear.
* Takes responsibility for decisions and follows through on commitments.
* Sets clear priorities and translates plans into action.
* Defines goals, timelines, and responsibilities with precision.
* Delivers results through structured planning and best practices.
* Demonstrated previous experience supporting the implementation, administration, and ongoing management of clinical or data management systems within a regulated (GxP) environment.
* Proven understanding of GxP system validation principles, including lifecycle validation, change management, periodic review, and inspection readiness.
* Working knowledge of information security and data privacy principles, ensuring compliant handling, access control, and protection of clinical and biometric data.
* Practical understanding of drug development and biometry processes, including how systems support clinical operations, data management, statistical programming, and reporting.
* Experience operating within Data Management and/or Clinical Development functions, supporting cross-functional clinical trial activities.
* Sound knowledge of…