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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 36000 - 60000 £ 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 in London employer: Ipsen Group
Contact Detail:
Ipsen Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Systems Lead in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how important it is to make those personal connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its systems landscape. Understand their GxP compliance needs and be ready to discuss how your experience aligns with their requirements. We want you to shine and show them you’re the perfect fit!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to system validation and project management. We recommend doing mock interviews with friends or mentors to build confidence and refine your answers.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive 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 in London
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 match your background. This will help us see how you fit into our team!
Tailor Your Application: Don’t just send a generic CV and cover letter! Customise your application to reflect the specific requirements of the role. Use the same language as the job description to show us you’re on the same page and genuinely interested in the position.
Showcase Relevant Experience: When detailing your experience, focus on your previous roles related to clinical or data management systems. Highlight any GxP experience and how you've contributed to system optimisations or user training. We want to see how you can bring value to our team!
Keep It Clear and Concise: Make sure your application is easy to read. Use bullet points for key achievements and keep paragraphs short. We appreciate clarity and precision, so ensure your application reflects that. And remember, apply through our website for the best chance!
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 your knowledge of GxP-compliant data repositories, EDC platforms, and statistical computing environments. Being able to discuss these confidently will show that you're prepared and serious about the role.
✨Engage with Real-World Scenarios
Prepare to discuss specific examples from your past experience where you've optimised or implemented systems in a regulated environment. Think about challenges you faced and how you overcame them. This will demonstrate your practical knowledge and problem-solving skills.
✨Showcase Your Communication Skills
Since the role involves engaging with various stakeholders, practice explaining complex topics in simple terms. You might be asked to clarify technical concepts, so being able to communicate effectively is key. Consider doing mock interviews with friends to refine this skill.
✨Be Ready for Training Discussions
Expect questions about your experience in developing training strategies and materials. Prepare to share how you've previously supported user onboarding and addressed training gaps. Highlighting your ability to enhance user experience through effective training will set you apart.
