Systems Lead

Ipsen; Paris; Sur place; EUR 65 000 - 85 000; Plein temps

Résumé du poste

A leading biopharmaceutical company is looking for a System Lead in Paris to manage the lifecycle of biometric GxP systems. The role includes overseeing compliance, implementing systems, and training users. Candidates should possess a Bachelor's degree in Life Sciences or IT and have comprehensive experience in regulated environments. Fluency in English is essential. This full-time position offers an opportunity to shape the future of clinical data management in an innovative company.

Qualifications

• Experience managing clinical or data management systems in a GxP environment.
• Deep understanding of regulatory compliance and system validation.
• Fluent in English (written and spoken).

Responsabilités

• Manage lifecycle of biometric GxP systems ensuring compliance.
• Lead system implementations and training across teams.
• Monitor system performance and user access.

Connaissances

GxP system validation principles

Project management methodology

Verbal and written communication

Relationship building

Formation

Bachelor's degree in Life Sciences or IT

Description du poste

Ipsen is a mid‑sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K., Ipsen addresses unmet medical needs through research and innovation.

Our passionate teams in over 40 countries strive daily to bring medicines to patients in 88 countries. We foster a human‑centric workplace that champions leadership, collaboration, excellence, and impact. At Ipsen, individuals are empowered to be their true selves and thrive alongside the company’s success, driving sustainable growth and real impact for patients and society.

Job Title: System Lead

Division / Function: Biometry

Location: Paris, France or London, U.K.

Summary & Purpose of the Position

The System Lead is responsible for end‑to‑end lifecycle management of Ipsen biometric GxP systems within their scope, including selection, validation, implementation, administration, operation, and decommissioning. Reporting to the Biometric Systems Director, the role independently manages assigned systems, makes risk‑based decisions within governance frameworks, and escalates as required. The System Lead ensures systems are fit for purpose, inspection‑ready, and compliant with regulatory GxP and business requirements, while acting as the primary point of contact for users, managing queries, issues, and change impacts to enable consistent and effective system use across Ipsen.

1. System Strategy Selection & Procurement

• Maintain expert knowledge of regulated clinical and analytical systems, including SCE, GxP‑compliant data repositories, EDC platforms, IRT/RTSM, clinical data integration and analytics solutions, data standards compliance tools, and 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 RTSM and forecasting system review and future implementation.

2. System Implementation & Transition Management

• Lead or support system implementations and expansions in collaboration with Ipsen IT Digital teams, QA, business users, and external vendors.
• Oversee migration of clinical and statistical studies, coordinating timelines, user readiness, and transition risks.
• Contribute to planning and execution of new system implementations.
• Produce and maintain system SOPs, user guides, training materials, and process documentation in alignment with Ipsen standards.

3. System Validation & Regulatory Compliance

• Maintain validated state of all GxP‑relevant systems (including SCE, GxP‑compliant data repositories, EDC, IRT/RTSM, etc.) per Ipsen SOPs and regulatory requirements.
• Coordinate validation activities for implementations, upgrades, patches, and expansions, including
  • Validation planning and timeline tracking
  • Development, execution, and review of UAT and validation documentation (plans, summaries, UAT scripts, validation packages)
• Work closely with IT and QA to keep systems inspection‑ready and compliant, monitoring periodic reviews.
• Monitor regulatory and industry developments impacting data integrity, electronic records, and validated systems.

4. System Usage Oversight & Performance Monitoring

• Oversee day‑to‑day system usage, performing periodic quality and compliance checks.
• Monitor performance metrics and key indicators (e.g., number of users, connections, study usage, processing volumes).
• Oversee external service providers for hosting, support, and maintenance.
• Review logged incidents, bugs, and enhancement requests with IT and vendors, ensuring timely resolution and prioritisation.

5. User Support, Training & Access Management

• Primary business support contact for users of biometric systems.
• Manage all user access requests (internal and external) with role‑based access and governance compliance.
• Deliver system training sessions and maintain training records, user guides, and documentation.
• Develop and update training materials and e‑learning content to support adoption and correct use.
• Collect user feedback on usability and training effectiveness, coordinating updates as required.

6. System Governance & Stakeholder Engagement

• Primary point of contact for system governance with IT Digital, QA, and vendors.
• Evaluate business impact of releases, upgrades, and changes; recommend implementation actions.
• Active member of the Change Advisory Board, contributing to prioritisation decisions.
• Organise and facilitate ad‑hoc governance meetings with owners and stakeholders.
• Communicate system strategy, roadmap, and planned changes to users and stakeholders.
• Participate in user group meetings and cross‑functional forums.
• Supervise subcontractors providing business or system support services where applicable.
• Act as backup for other system‑related activities as required.

7. Continuous Improvement & Process Optimisation

• Monitor user requests, support tickets, and usage patterns to identify trends and gaps.
• Propose targeted training, process improvements, or system enhancements to address recurring needs.
• Author and update system SOPs and process documentation.
• Recommend system and documentation improvements to enhance efficiency, compliance, and user experience.
• Stay aware of internal and external changes impacting usage and processes.
• Support decommissioning of systems, coordinating data retention, archiving, access, and documentation in line with SOPs.
• Ensure decommissioning activities are documented, compliant, and controlled.
• Collaborate with IT and QA to maintain data integrity and audit readiness during retirement.

8. System Decommissioning & Legacy Management

• Support planned decommissioning, coordinating data retention, archiving, access, and regulatory documentation per SOPs.
• Ensure compliance and control throughout the decommissioning process.
• Collaborate with IT and QA to ensure data integrity and audit readiness.

9. Mergers & Acquisitions & System Integration

• Support assessment of inherited systems and processes through acquisitions.
• Contribute to data integration strategies and transition planning for acquired systems and studies.
• Temporarily assume administration of equivalent systems or processes during transition periods until convergence is achieved.

10. Environment Health & Safety (EHS)

• Comply with applicable EHS regulations, policies, and procedures.
• Report risks, incidents, malfunctions, and improvement opportunities.
• Participate in mandatory EHS training activities.

Knowledge & Experience (essential)

• Experience supporting implementation, administration, and ongoing management of clinical or data management systems in a regulated (GxP) environment.
• Deep understanding of GxP system validation principles, lifecycle validation, change management, periodic review, and inspection readiness.
• Knowledge of information security and data privacy principles, ensuring compliant handling, access control, and protection of clinical and biometric data.
• Understanding of drug development and biometry processes, including how systems support clinical operations, data management, statistical programming, and reporting.
• Experience operating within Data Management or Clinical Development functions, supporting cross‑functional trial activities.
• Project management methodology knowledge, capable of planning, coordinating, and delivering system activities across 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 system development, validation, and maintenance.

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 relationships with a wide range of stakeholders including business users, IT, QA, and vendors.
• Strong verbal and written communication skills, explaining complex system or regulatory topics clearly and effectively.
• High attention to detail, producing 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).

Employment Type: Full‑Time

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