Systems Lead

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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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 Ipsens 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 Ipsens biometric systems landscape by applying divisional technical competency frameworks and best practices.

WHAT - Main Responsibilities & Technical Competencies

1. System Strategy Selection & Procurement

• Maintain expert knowledge of Ipsens regulated clinical and analytical systems landscape including statistical computing environments (SCE) GxPcompliant 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.

2. System Implementation & Transition Management

• Lead or support system implementations and expansions in collaboration with Ipsen IT Digital teams Quality Assurance business users and external vendors.
• Oversee the migration of clinical and statistical studies within systems including coordination of timelines user readiness and transition risks.
• Contribute to the 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

• Ensure continuous maintenance of the validated state of all GxP-relevant systems including but not limited to including SCE GxPcompliant 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.

4. System Usage Oversight & Performance Monitoring

• Oversee day-to-day system usage across all supported platforms by performing periodic quality and compliance checks.
• Monitor system performance metrics and key indicators (e.g. number of users connections study usage processing volumes).
• Provide oversight of external service providers responsible for system hosting support and maintenance.
• Regularly review the status of logged incidents bugs and enhancement requests with IT and system vendors ensuring timely resolution and appropriate prioritisation.

5. User Support Training & Access Management

• 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.

6. System Governance & Stakeholder Engagement

• Serve as the primary point of contact for system governance with Ipsen IT Digital Quality Assurance teams and system vendors.
• Evaluate the business impact of system releases upgrades and configuration changes and provide clear recommendations to system owners regarding implementation.
• Act as an active member of the Change Advisory Board (CAB) contributing to prioritisation decisions for enhancements and defect resolution.
• Organise and facilitate ad-hoc governance meetings with system owners and key business stakeholders to review and validate proposed changes.
• 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.
• May act as back-up for other system-related activities within DM Systems and Standards as reasonably required.

7. Continuous Improvement & Process Optimisation

• 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.

8. System Decommissioning & Legacy Management

• Support the planned decommissioning of systems including coordination of data retention archiving access and regulatory documentation in line with Ipsen SOPs.
• Ensure decommissioning activities are planned documented and executed in a compliant and controlled manner.
• Collaborate with IT and Quality Assurance to ensure continuity of data integrity and audit readiness throughout system retirement activities.

9. Mergers Acquisitions & System Integration

• Support assessment of systems and processes inherited through acquisitions.
• Contribute to data integration strategies and transition planning for acquired systems and studies.
• Where required 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.
• Contribute to site EHS performance by reporting risks incidents malfunctions and improvement opportunities.
• 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):

• Bachelors 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).

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