Head eTMF Systems

Title:

Head eTMF Systems

Company:

Ipsen Biopharm Ltd

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 company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at  and follow our latest news on Linked In and Instagram.

Job Description:

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 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. 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 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.

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 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.

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 &…