Head eTMF Systems

Cookie Notice**WHAT -** **Summary & Purpose of the Position****WHAT -** **Main Responsibilities & Technical Competencies*** Lead the global eTMF strategy and roadmap, ensuring alignment with Ipsen’s R&D and CDO transformation initiatives and operating model.* 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.### Get In TouchIntroduce yourself to our recruiters and we’ll get in touch if there’s a role that seems like a good match.#J-18808-Ljbffr…