Head eTMF Systems

The Head eTMF (Electronic Trial Master File) Systems is a strategic and operational leader responsible for the oversight, management and continuous improvement of Ipsen’s eTMF ecosystem, ensuring that Trial Master Files are always inspection ready and fully compliant with regulatory standards (e.g. ICH‑GCP, data protection regulations). This role owns Ipsen’s Veeva Vault eTMF system from a business perspective, ensuring it effectively supports Ipsen’s R&D and Clinical Development Operations transformation agenda. It drives strategy, governance, processes, training and user adoption across functions and geographies, working closely with Clinical Operations, R&D IT, Quality, Digital and external vendors/CROs.

Main Responsibilities & Technical Competencies

• Strategic Leadership & Governance: 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 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.
• System Implementation & Oversight: Lead the governance framework associated with required updates, validation and implementation of eTMF system releases (e.g. Veeva Vault upgrades, integrations). Define and maintain eTMF standards (SOPs, business rules, templates, taxonomies and performance metrics) and ensure all end‑users are trained and qualified. Own and monitor TMF performance objectives and metrics (e.g. completeness, timeliness, quality), and drive corrective and preventive actions where needed. Monitor TMF health status (including system usage and quality checks) to ensure consistent compliance with SOPs and regulatory standards. Drive development of innovative, risk‑based eTMF operational processes that inform business decisions, mitigate compliance risk and embed leading practices.
• Vendor & Stakeholder Management: Establish and lead eTMF functional governance with CROs and other external partners to ensure alignment on Ipsen processes, timelines and quality standards. Drive standardization of eTMF practices between Ipsen’s internal teams, eTMF vendor and CROs/third‑party providers. Partner with R&D IT, Digital and other third‑party vendors on eTMF services, integrations and contractor management, ensuring appropriate governance forums are in place. Ensure vendor performance meets contractual obligations and Ipsen standards, using KPIs and dashboards to provide visibility and enable proactive issue management.
• Process Improvement & Compliance: Promote a risk‑based approach to maintaining a continuous state of audit and inspection readiness across all TMFs. Ensure eTMF processes and system usage comply with applicable regulations and guidelines (e.g. ICH‑GCP, data protection, local regulatory expectations) and Ipsen SOPs. Identify, assess and elevate significant quality and compliance risks, lead or support investigations, root‑cause analysis and remediation initiatives. Identify and lead eTMF system and process improvement initiatives, using data insights, user feedback and industry benchmarks. Collaborate with CDO leadership, Quality and other internal stakeholders on SOP development, controlled document updates and cross‑functional process harmonization.
• Integration & Acquisition Support: Provide eTMF leadership and expertise for integration of acquired companies, licensed assets or strategic partnerships. Collaborate with the CDO Integration Lead and other workstreams to plan and deliver eTMF migration activities, ensuring robust governance, data integrity and timely adoption of Ipsen standards.
• User Support, Change Management & Training: 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 an escalation point for complex user issues and recurring system challenges and ensure sustainable solutions are implemented.
• Team Leadership & People Management: 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.

Key Technical Competencies

• 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.

Behavioural Competencies

• Excellence in Execution: Plans and prioritises work to ensure TMFs are always inspection ready, even under pressure or tight timelines. Translates strategy into clear goals, timelines and KPIs for the eTMF team and stakeholders. Drives a culture of operational discipline, continuous improvement and best practice sharing across studies and regions.
• Manages Complexity: Makes sense of complex and sometimes contradictory information across systems, vendors and studies to solve problems effectively. Simplifies complexity for others by providing clear guidance, standards and decision frameworks. Anticipates issues and scenarios (e.g. inspections, integrations, migrations) and prepares robust, pragmatic solutions.
• Collaborates & Builds Effective Teams: Builds strong partnerships with Clinical Operations, R&D IT, Quality, Digital, CROs and other stakeholders to deliver shared objectives. Creates a high‑trust, inclusive environment where diverse perspectives are valued and constructive challenge is encouraged. Leverages strengths across the network (internal and external) to solve problems, standardise ways of working and accelerate outcomes for patients.
• Communicates Effectively & Influences: Communicates complex system, process and regulatory topics in a clear, accessible way for different audiences (e.g. study teams, IT, leadership, inspectors). Uses data, stories and patient‑centred arguments to influence decisions and secure alignment on eTMF priorities and investments. Listens actively, seeks feedback and adapts style to build trust and commitment across cultures and functions.
• Ensures Accountability: 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 encouraging the same in the team.

Knowledge & Experience (essential)

• 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 optimising 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.

Knowledge & Experience (preferred)

• 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.

Education / Certifications (essential)

• Bachelor’s degree (or equivalent) in Life Sciences, Pharmacy, Information Technology or a related discipline.

Education / Certifications (preferred)

• Advanced degree (e.g. MSc, PharmD, PhD, MBA) in a relevant discipline.
• Relevant professional certifications (e.g. GCP, clinical research, project management) are an advantage.

Language(s) (essential)

• English – fluent (written and spoken).

Language(s) (preferred)

• Additional languages relevant to Ipsen’s key geographies are an asset.