Head of Study, Site Management and Monitoring

A senior leadership role within Clinical Development Operations, accountable for the strategic oversight and operational excellence of Ipsen’s global Country Operations activities under a Functional Service Provider (FSP) delivery model. Provides end‑to‑end leadership across the clinical trial lifecycle at country and site level, from feasibility and site selection through study start‑up, site management, monitoring (risk based), study close‑out, and inspection readiness. Drives transition to a scalable, performance‑driven FSP framework, ensuring compliant, high‑quality execution with clear process ownership and governance over FSP partners.

Key collaboration: Partners with CDO TA Clinical Operations, Quality, Data Management, Strategy and Operations, Biostatistics, Medical, Safety, Regulatory Affairs, and Country Medical Affairs to enable timely study delivery, robust oversight, and inspection‑ready execution. Defines Ipsen’s global Site Engagement Strategy and leads prioritization of strategic sites to build long‑term partnerships.

Main Responsibilities & Technical Competencies

• Trial Delivery
  • Establish partnerships with FSP provider(s) to deliver Ipsen’s portfolio.
  • Partner with functional leaders and FSPs to ensure trials are delivered on time, within budget, and in line with quality standards.
  • Responsible for country project delivery to agreed timelines, including patient recruitment targets.
  • Build, develop, and motivate a high‑performing internal oversight team and ensure FSP providers bring appropriate resources.
  • Drive continuous improvement of Clinical Operations processes to optimise development speed, quality, and regulatory compliance.
• Strategic Leadership & Operating Model Definition
  • Define Ipsen’s global Study, Site Management and Monitoring strategy with CDO LT, aligned with the global FSP operating model.
  • Lead design, implementation, and optimization of the FSP‑based Country Operations and Monitoring model.
  • Serve as accountable owner for country/site‑level operational processes and clarify roles between Ipsen and FSP partners.
  • Translate portfolio needs into scalable solutions across regions and therapeutic areas.
  • Contribute to governance forums, representing site‑level execution, risks, and performance trends, and support strategic planning and budget management.
• FSP Oversight & Governance
  • Provide end‑to‑end oversight of FSP partners for: country feasibility and site identification; site selection and initiation; study start‑up activities (including regulatory interfaces); recruitment to targets; study, site management and monitoring; study close‑out and inspection readiness.
• Cross Country and In‑Country Study Management
  • Collaborate with CDO Partnerships and global Procurement to define governance structures with KPIs, SLAs, escalation pathways, and performance standards.
  • Develop a clear Study/Study, Site Management and Monitoring Process Framework; ensure consistent Ipsen standards across FSP‑delivered activities.
  • Drive a strong partnership culture with FSPs while maintaining sponsor oversight and independence.
  • Lead escalation and remediation of performance, quality, or compliance issues at country or site level.
• Country Feasibility, Site Selection & Start‑Up Oversight
  • Establish standardized, data‑driven approaches to country feasibility and site selection with global functions.
  • Oversee site feasibility execution and validation to support enrolment projections and operational planning.
  • Ensure efficient, compliant start‑up, including site contracting, budget negotiations, regulatory and ethics submissions, and site initiation readiness.
  • Monitor start‑up performance metrics and address delays or bottlenecks proactively.
• Site Management & Monitoring Excellence
  • Partner with Data Management and Central Monitoring on RBQM strategies in line with regulatory expectations.
  • Ensure effective monitoring delivery (on‑site, remote, centralized) including supplier oversight for product compliance and data quality.
  • Coordinate with Data Management, Biostatistics, and Central Monitoring for integrated risk mitigation.
  • Drive consistency in site execution, issue management, and protocol adherence across regions.
• Study Close‑Out & Inspection Readiness
  • Ensure timely study and site close‑out activities; maintain continuous inspection readiness at site and country levels.
  • Oversee TMF completeness/quality and essential document quality; support regulatory inspections as senior sponsor representative for Study, Site Management and Monitoring.
• Site Engagement Strategy
  • Define and own Ipsen’s global Site Engagement Strategy aligned to clinical priorities and portfolio growth.
  • Identify priority and strategic sites and differentiate: global/regional partners, high‑performing operational sites, and development sites critical to pipeline growth.
  • Collaborate with Medical to ensure robust, differentiated site engagement.
• IPSEN Team Leadership
  • Define, build, and grow the internal Study, Site Management and Monitoring organization.
  • Oversee internal CTMs managing study management within country clusters; partner with Training to ensure a skilled delivery team.
• Quality, Compliance & Risk Management
  • Ensure all activities comply with ICH‑GCP, regional regulations, Ipsen SOPs and quality standards.
  • Embed proactive risk identification and mitigation at site and country level; work with Quality Assurance on audit findings and CAPAs.
  • Promote a culture of quality, accountability, and patient safety with internal teams and FSP partners.
• Performance Management, Metrics & Continuous Improvement
  • Define and oversee a robust performance management framework; use data to identify trends, risks, and drive improvements.
  • Improve reporting capabilities (dashboards, KPIs) and champion innovation across site‑level processes.
• Leadership, Stakeholder Management & Culture
  • Lead and develop high‑performing internal teams; interface with senior stakeholders across Clinical Development, Quality, Regulatory, Medical, and Global Operations.
  • Represent Ipsen externally with investigators, partners, and vendors; foster collaboration and continuous learning.

Knowledge & Experience

• 15+ years in pharmaceutical/biotech with transformational leadership across global cross‑functional teams.
• 15+ years of experience leading Country Operations teams across trial types; extensive clinical operations experience.
• Deep knowledge of drug development, ICH‑GCP, 21 CFR Part 11, and major Health Authority regulations; audit/inspection readiness and FDA/EMA inspections.
• Experience with large‑scale organizational change, project management, agile mindset, and effective cross‑level communication.
• Strong understanding of clinical systems (eTMF, CTMS, QMS) and business process design.

Education / Certifications

• Essential: Bachelor’s degree in a scientific discipline or general management.
• Preferred: Advanced degree (Masters, MBA, MD, PhD).
• Language: English (essential).

We are committed to inclusion and equal opportunities. If you require adjustments during the application process, please inform the recruitment team. This description reflects the role and does not constitute a job offer or commitment to employment.