Head eTMF Systems
Ipsen
Head Etmf Systems
Division / Function: R&D / Clinical Development Operations (CDO)
Location: London (UK) / Paris (FR) / Boston (US)
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.
Main Responsibilities & Technical Competencies
- Strategic Leadership & Governance
- System Implementation & Oversight
- Vendor & Stakeholder Management
- Process Improvement & Compliance
- Integration & Acquisition Support
- User Support, Change Management & Training
- Team Leadership & People Management
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 Required
- Excellence in Execution (Hands Making a Real Impact)
- Manages Complexity (Head Thinking Dexterity)
- Collaborates & Builds Effective Teams (Hands / Heart Making a Real Impact & Social Agility)
- Communicates Effectively & Influences (Heart Being Intentional)
- Ensures Accountability (Hands Making a Real Impact)
Knowledge & Experience
- 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.
Education / Certifications
- Bachelor's degree (or equivalent) in Life Sciences, Pharmacy, Information Technology or a related discipline.
- 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)
- English fluent (written and spoken).
- Additional languages relevant to Ipsen's key geographies are an asset.
Vacancy posted 3 days ago
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