Systems Lead

Job Title:

System Lead

Division / Function:

Biometry

Location:

Paris, France or London, UK

WHAT - Summary & Purpose of the Position

The System Lead is responsible for the end-to-end lifecycle management of Ipsen biometric GxP systems within their scope, including system selection, validation, implementation, administration, operation, and decommissioning. Reporting to the Biometric Systems Director within the DM, Systems and Standards division, the role independently manages assigned systems and activities, making risk-based decisions within established governance frameworks and escalating as required.

The System Lead ensures that biometric systems are fit for purpose, inspection-ready, and compliant with regulatory, GxP, and business requirements, supporting Ipsen's global data and systems strategy. Acting as the primary point of contact for system users, the role manages system-related queries, issues, and change impacts, enabling consistent and effective system use across Ipsen.

Working in close collaboration with Clinical Operations, Clinical Trial Excellence, Data Management, Statistical Programming, Statistics, Quality, Digital, IT, and external vendors, the System Lead delivers system initiatives and continuous improvements that support reliable data, standardised processes, and scalable global deployment. The role contributes to the evolution of Ipsen's biometric systems landscape by applying divisional technical competency frameworks and best practices.

WHAT - Main Responsibilities & Technical Competencies

1. System Strategy, Selection & Procurement

2. 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.

3. Proactively assess system capabilities and limitations to recommend optimisations, replacements, or new solutions aligned with business, regulatory, and data strategy needs.
4. Engage with business users and SMEs to gather, analyse, and document user requirements for new systems, enhancements, or replacements.

5. Actively participate in RFP activities, including requirements definition, vendor evaluation, and selection, notably for the ongoing RTSM and forecasting system review and future implementation.

6. System Implementation & Transition Management

7. Lead or support system implementations and expansions in collaboration with Ipsen IT, Digital teams, Quality Assurance, business users, and external vendors.

8. Oversee the migration of clinical and statistical studies within systems, including coordination of timelines, user readiness, and transition risks.
9. Contribute to the planning and execution of new system implementations.

10. Produce and maintain system SOPs, user guides, training materials, and process documentation in alignment with Ipsen standards.

11. System Validation & Regulatory Compliance

12. 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.

13. Coordinate validation activities for system implementations, upgrades, patches, and expansions, including:
14. Validation planning and timeline tracking
15. Development, execution, and review of UAT and validation documentation (Validation Plans and Summaries, UAT scripts, validation packages).
16. Work closely with IT and Quality Assurance to ensure systems remain inspection-ready and in a constant state of compliance with periodic reviews.

17. Monitor regulatory and industry developments impacting data integrity, electronic records, and validated systems.

18. System Usage Oversight & Performance Monitoring

19. Oversee day-to-day system usage across all supported platforms by performing periodic quality and compliance checks.

20. Monitor system performance metrics and key indicators (e.g. number of users, connections, study usage, processing volumes).
21. Provide oversight of external service providers responsible for system hosting, support, and maintenance.

22. Regularly review the status of logged incidents, bugs, and enhancement requests with IT and system vendors, ensuring timely resolution and appropriate prioritisation.

23. User Support, Training & Access Management

24. Act as the primary business support contact for users of biometric systems.

25. Manage all user access requests (internal and external), ensuring appropriate role-based access and compliance with governance requirements.
26. Deliver system training sessions and maintain training records, user guides, and supporting documentation.
27. Develop, update, and maintain training materials and e-learning content to support system adoption and correct use.

28. Collect user feedback on system usability and training effectiveness and coordinate updates as required.

29. System Governance & Stakeholder Engagement

30. Serve as the primary point of contact for system governance with Ipsen IT, Digital, Quality Assurance teams, and system vendors.

31. Evaluate the business impact of system releases, upgrades, and configuration changes, and provide clear recommendations to system owners regarding implementation.
32. Act as an active member of the Change Advisory Board (CAB), contributing to prioritisation decisions for enhancements and defect resolution.
33. Organise and facilitate ad-hoc governance meetings with system owners and key business stakeholders to review and validate proposed changes.
34. Communicate system strategy, roadmap, and planned changes to users and stakeholders.
35. Participate in user group meetings and cross-functional forums.
36. Supervise subcontractors providing business or system support services where applicable.

37. May act as back-up for other system-related activities within DM, Systems and Standards as reasonably required.

38. Continuous Improvement & Process Optimisation

39. Monitor user requests, support tickets, and usage patterns to identify trends, recurring issues, or training gaps.

40. Propose targeted training initiatives, process improvements, or system enhancements to address recurring needs.
41. Author and update system-related SOPs and process documentation as required.
42. Recommend system and documentation improvements to improve efficiency, compliance, and user experience.

43. Maintain awareness of internal and external changes impacting system usage and business processes.

44. System Decommissioning & Legacy Management

45. Support the planned decommissioning of systems, including coordination of data retention, archiving, access, and regulatory documentation in line with Ipsen SOPs.

46. Ensure decommissioning activities are planned, documented, and executed in a compliant and controlled manner.

47. Collaborate with IT and Quality Assurance to ensure continuity of data integrity and audit readiness throughout system retirement activities.

48. Mergers, Acquisitions & System Integration

49. Support assessment of systems and processes inherited through acquisitions.

50. Contribute to data integration strategies and transition planning for acquired systems and studies.

51. Where required, temporarily assume administration of equivalent systems or processes during transition periods until convergence is achieved.

52. Environment, Health & Safety (EHS)

53. Comply with applicable EHS regulations, policies, and procedures.

54. Contribute to site EHS performance by reporting risks, incidents, malfunctions, and improvement opportunities.
55. Participate in mandatory EHS training activities.

HOW - Behavioural Competencies Required

Manage Complexity

• Makes sense of complex and sometimes conflicting information.
• Evaluates options and selects practical, high-impact solutions.
• Focuses on what matters most and prioritises decisions accordingly.

Ensures Accountability

• Clearly defines ownership and accountability for outcomes.
• Encourages clarification when responsibilities are unclear.
• Takes responsibility for decisions and follows through on commitments.

Communicates Effectively

• Listens actively and respects different perspectives.
• Communicates clearly, transparently, and with impact.
• Tailors messages and uses clear structure to support understanding.

Collaborates

• Works openly across functions and organisational boundaries.
• Removes barriers and promotes shared ways of working.
• Applies learning and ideas to drive continuous improvement.
• Demonstrates a service-oriented mindset with a genuine desire to support and enable users.

Excellence in Execution

• Sets clear priorities and translates plans into action.
• Defines goals, timelines, and responsibilities with precision.
• Delivers results through structured planning and best practices.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 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.

Knowledge & Experience (preferred):

• 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.

Skills & Capabilities

• 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.

Education / Certifications (essential):

• Bachelor's degree in Life Sciences, Information Technology, Data Sciences, or a related discipline, providing a solid foundation in regulated environments and data-driven systems.

Language(s) (essential):

• Fluent English (written and spoken).