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- Tasks: Lead and optimise clinical systems to ensure compliance and efficiency.
- Company: Ipsen, a leader in biopharmaceuticals with a focus on innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in clinical development while working with cutting-edge technology.
- Qualifications: Experience in clinical systems and understanding of GxP regulations required.
- Other info: Collaborative environment with a focus on continuous improvement and user support.
The predicted salary is between 48000 - 72000 £ per year.
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 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.
Systems Lead employer: Ipsen Group
Contact Detail:
Ipsen Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Systems Lead
✨Tip Number 1
Network like a pro! Reach out to people in your industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their systems landscape and be ready to discuss how your experience aligns with their needs. We want to see you shine!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience with GxP systems and how you've tackled challenges in the past.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression. And remember, apply through our website for the best chance at landing that Systems Lead role!
We think you need these skills to ace Systems Lead
Some tips for your application 🫡
Know the Role Inside Out: Before you start writing, make sure you understand the Systems Lead role and its responsibilities. Dive into the job description and highlight key skills and experiences that align with what we’re looking for. This will help you tailor your application to show us you’re the perfect fit!
Showcase Your Experience: When detailing your experience, focus on specific examples that demonstrate your expertise in GxP systems and clinical data management. Use clear, concise language to explain how your past roles have prepared you for this position. We want to see how you’ve tackled challenges and delivered results!
Be Clear and Concise: Keep your application straightforward and to the point. Avoid jargon unless it’s relevant to the role. We appreciate clarity, so make sure your writing is easy to read and flows well. This shows us you can communicate effectively, which is crucial for the Systems Lead position.
Apply Through Our Website: Once you’ve polished your application, head over to our website to submit it. Applying directly through our site ensures your application gets to the right people quickly. Plus, it’s super easy! We can’t wait to see what you bring to the table!
How to prepare for a job interview at Ipsen Group
✨Know Your Systems Inside Out
Make sure you have a solid understanding of the clinical and analytical systems mentioned in the job description. Brush up on GxP-compliant data repositories, EDC platforms, and statistical computing environments. Being able to discuss these confidently will show that you're not just familiar with the terms but can also apply them.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to demonstrate how you've handled system validations or user training in the past. Think of specific examples where you’ve optimised a system or resolved a user issue. This will help you illustrate your problem-solving skills and experience effectively.
✨Engage with Stakeholders
Since the role involves working closely with various stakeholders, be ready to discuss how you’ve collaborated with IT, Quality Assurance, and business users in previous roles. Highlight your communication skills and how you’ve built relationships to ensure project success.
✨Stay Updated on Regulatory Standards
Familiarise yourself with international regulatory standards like ICH, GCP, and GDPR. Be prepared to discuss how these regulations impact system validation and maintenance. Showing that you’re proactive about staying informed will impress your interviewers.
