Head eTMF Systems

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Head eTMF (Electronic Trial Master File) Systems

Division / Function:

R&D / Clinical Development Operations (CDO)

Location:

London (UK) / Paris (FR) / Boston (US)

WHAT - Summary & Purpose of the Position

The Head eTMF (Electronic Trial Master File) Systems is a strategic and operational leader responsible for the oversight management and continuous improvement of Ipsens 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 Ipsens Veeva Vault eTMF system from a business perspective ensuring it effectively supports Ipsens R&D and Clinical Development Operations transformation agenda. The role drives strategy governance processes training and user adoption across functions and geographies working in close partnership with Clinical Operations R&D IT Quality Digital and external vendors/CROs.

WHAT - Main Responsibilities & Technical Competencies

1. Strategic Leadership & Governance

• Lead the global eTMF strategy and roadmap ensuring alignment with Ipsens 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.

2. 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.

3. 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 Ipsens 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.

4. 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 escalate 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.

5. 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.

6. 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 escalation point for complex user issues and recurring system challenges and ensure sustainable solutions are implemented.

7. 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 Ipsens 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.

HOW - Behavioural Competencies Required

1. Excellence in Execution (Hands Making a Real Impact)

• Plans and prioritizes work to ensure TMFs are always inspection ready even under pressure or tight timelines.
• Translate 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.

2. Manages Complexity (Head Thinking Dexterity)

• 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.

3. Collaborates & Builds Effective Teams (Hands / Heart Making a Real Impact & Social Agility)

• Build strong partnerships with Clinical Operations R&D IT Quality Digital CROs and other stakeholders to deliver shared objectives.
• Creating 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 standardize ways of working and accelerate outcomes for patients.

4. Communicates Effectively & Influences (Heart Being Intentional)

• Communicates complex system process and regulatory topics in a clear accessible way for different audiences (e.g. study teams IT leadership inspectors).
• Use data stories and patient-centric 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.

5. Ensures Accountability (Hands Making a Real Impact)

• 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 Ipsens values and ways of being by taking ownership for successes failures and learning and by encouraging the same in the team.

HOW - Knowledge & Experience

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 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.

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):

• Bachelors 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 Ipsens key geographies are an asset.