Systems Lead

Ipsen Group; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Greater London is looking for a Clinical Systems Manager to oversee the management and validation of regulated clinical systems. In this role, you will ensure compliance with GxP regulations, engage with business users to gather requirements, and develop training materials to support system adoption. This position requires a strong understanding of clinical data management and experience in a regulated environment.

Benefits

Health insurance

Training and development opportunities

Flexible working hours

Qualifications

• Experience in managing clinical or data management systems.
• Understanding of GxP validation principles.
• Ability to work in a matrix organization.

Responsibilities

• Maintain expert knowledge of Ipsen’s clinical systems landscape.
• Engage with business to gather requirements for new systems.
• Ensure systems remain inspection-ready and compliant.

Skills

Expert knowledge of clinical systems

GxP compliance knowledge

Project management skills

Strong communication skills

Training strategy development

Education

Degree in Life Sciences or related field

Tools

Statistical Computing Environments

Electronic Data Capture platforms

Validation software

Job description

Cookie Notice**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 project management methodologies, with the ability to plan, coordinate, and deliver system-related activities across multiple stakeholders.* Experience developing and implementing training strategies, including user onboarding, role-based training, and maintenance of training materials.* Experience overseeing external vendors or subcontractors, including service delivery monitoring, issue escalation, and performance oversight.* Strong knowledge of international regulatory standards (e.g. ICH, GCP, GAMP5, 21 CFR Part 11, GCDMP, GDPR) and their impact on the development, validation, and maintenance of systems used in clinical development.* Experience working in a matrix organisation, managing priorities across functions, geographies, and governance structures.* Exposure to global system deployments and support of multi-study or multi-region system usage.* Experience contributing to continuous improvement initiatives related to systems, processes, or user enablement.* Ability to build effective working relationships with a wide range of stakeholders, including business users, IT, Quality, and vendors.* Strong verbal and written communication skills, with the ability to explain complex system or regulatory topics clearly and effectively.* High attention to detail with a demonstrated ability to produce accurate, high-quality work within agreed timelines.* A collaborative mindset and genuine desire to support and enable others through reliable systems and clear guidance.### Get In TouchIntroduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.