At a Glance
- Tasks: Lead global eTMF strategy and ensure compliance in clinical study management.
- Company: Join a leading biopharma company focused on innovation and collaboration.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Be part of a globally minded team with excellent career advancement opportunities.
- Why this job: Make a real impact in clinical excellence and drive change in a dynamic environment.
- Qualifications: Expertise in eTMF processes and strong leadership skills required.
The predicted salary is between 80000 - 100000 £ per year.
Summary & Purpose of the Position
Lead the global eTMF strategy and roadmap, ensuring alignment with Ipsen’s R&D and CDO transformation initiatives and operating model.
Main Responsibilities & Technical Competencies
- Act as the eTMF business process owner, accountable for the quality, compliance and fitness-for-purpose of TMF content, processes and systems.
- Ensure TMF operating standards, electronic clinical systems, data standards and related business processes support compliant, efficient end-to-end study management.
- Serve as subject matter expert (SME) for eTMF management and inspection readiness, representing the function in audits, inspections and key governance forums.
- Provide strategic oversight and governance of all eTMF-related activities and vendors, ensuring decisions are data-driven and risk-based.
- Ensure fit-for-purpose training programmes, user guides, SOPs and e-learning materials are in place, regularly reviewed and updated.
- Drive effective change management and user adoption for new releases, process changes and integrations, in partnership with CDO, R&D IT and local teams.
- Collect, monitor and act on user feedback to improve system usability, training effectiveness and ways of working.
- Act as escalation point for complex user issues and recurring system challenges and ensure sustainable solutions are implemented.
- Lead, coach and develop the eTMF team to deliver high performance, strong collaboration and a culture of continuous improvement.
- Set clear objectives, priorities and development plans for team members, aligned to Ipsen’s leadership competencies and ways of being.
- Foster a collaborative, inclusive and globally minded team culture, working across functions, geography and time zones.
- Demonstrate strong leadership in driving eTMF user acceptance and inspection-readiness as a core enabler of clinical excellence.
- Expert knowledge of TMF/eTMF processes, regulatory requirements and inspection-readiness standards.
- In-depth experience with Veeva Vault eTMF (or similar) including configuration, validation, release management and integrations.
- Strong understanding of GxP system validation, data integrity principles and clinical trial lifecycle.
- Ability to design and implement TMF metrics, dashboards and data-driven improvement initiatives.
- Strong vendor and CRO governance skills, including contract oversight and performance management.
- Sets and reinforces clear accountabilities for eTMF quality, completeness and timeliness across all stakeholders (internal teams, CROs, vendors).
- Holds self and others to commitments, following through agreed actions and ensuring issues are addressed at root cause.
- Role-models Ipsen’s values and ways of being by taking ownership for successes, failures and learning, and by encouraging the same in the team.
- Demonstrated expertise in TMF/eTMF management within the pharmaceutical or biotech industry, including deep understanding of TMF Reference Model, ICH-GCP and inspection expectations.
- Proven track record in owning and optimizing an enterprise eTMF platform (preferably Veeva Vault), including configuration changes, release management, validation and integrations with other clinical systems.
- Experience designing and implementing TMF standards, governance frameworks, SOPs, business rules and training for global user communities.
- Strong experience managing relationships and performance with CROs and other external vendors for TMF/eTMF services.
- Evidence of leading cross-functional, global initiatives and successfully implementing change in a regulated environment.
- Demonstrated ability to interpret data/metrics to drive continuous improvement and informed decision-making.
- Experience in mid-sized global biopharma/biotech organisations with evolving R&D operating models.
- Experience with system migrations and eTMF integration in the context of acquisitions, divestments or partnerships.
- Previous leadership of distributed/global teams and virtual collaboration environments.
- Familiarity with broader clinical systems landscape (e.g. CTMS, RTSM, EDC) and data flows into TMF.
Head eTMF Systems employer: Ipsen Group
Ipsen is an exceptional employer that prioritises employee growth and development, particularly in the dynamic field of eTMF management. With a strong commitment to fostering a collaborative and inclusive work culture, employees are empowered to lead global initiatives while benefiting from comprehensive training programmes and clear career progression paths. Located in a vibrant environment, Ipsen offers unique opportunities to engage with cutting-edge technology and contribute to meaningful advancements in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Head eTMF Systems
✨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 all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your responses to highlight your experience with eTMF systems and compliance. Show them you’re the perfect fit for their team!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role.
✨Tip Number 4
Apply through our website for the best chance at landing a role with us. We love seeing candidates who take the initiative to connect directly with our team. Plus, it shows you’re serious about joining our mission!
We think you need these skills to ace Head eTMF Systems
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience with eTMF systems and compliance. We want to see how your skills align with our needs, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills:As a Head of eTMF Systems, leadership is key! Use your application to demonstrate your experience in leading teams and driving change. Share specific examples of how you've fostered collaboration and improved processes in previous roles.
Be Data-Driven:We love numbers! When discussing your past experiences, include metrics or data that illustrate your impact. Whether it’s improving system usability or enhancing compliance, showing us the results of your work can really make your application stand out.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at Ipsen Group
✨Know Your eTMF Inside Out
Make sure you have a solid understanding of eTMF processes and the specific requirements for the role. Brush up on your knowledge of Veeva Vault and be ready to discuss how you've optimised eTMF platforms in the past.
✨Showcase Your Leadership Skills
Prepare examples that highlight your experience in leading teams and driving change. Be ready to discuss how you've fostered collaboration and inclusivity in previous roles, as this is key for the Head eTMF Systems position.
✨Be Data-Driven
Since the role involves making data-driven decisions, come prepared with examples of how you've used metrics to improve processes or systems. This will demonstrate your analytical skills and commitment to continuous improvement.
✨Understand the Bigger Picture
Familiarise yourself with Ipsen’s R&D and CDO transformation initiatives. Showing that you understand how the eTMF strategy aligns with broader company goals will set you apart from other candidates.
