The Head of Study, Site Management and Monitoring is 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. The role 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 (inc Risk Based), study close‑out, and inspection readiness.
This position is a critical enabler of Ipsen’s future operating model, driving the transition from traditional outsourcing approaches to a scalable, performance‑driven FSP framework. The role ensures consistent, compliant, and high‑quality execution across countries and studies while maintaining clear process ownership, governance, and oversight of FSP partners delivering site‑level activities on Ipsen’s behalf.
Acting as the single accountable owner for Study, Site Management and Monitoring strategy, the Head of Study, Site Management and Monitoring ensures alignment with clinical development objectives, regulatory expectations, and quality standards. The role partners closely 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 at all times.
The Head of Study, Site Management and Monitoring will define and execute Ipsen’s global Site Engagement Strategy, ensuring a portfolio‑led, data‑driven approach to investigator relationships. Lead the identification and prioritization of strategic sites, fostering long‑term partnerships that enhance site experience, operational performance, and Ipsen’s reputation as a sponsor of choice.
As a key member of the CDO leadership team, this role shapes Ipsen’s long‑term site engagement and monitoring strategy, focusing on operational efficiency, risk‑based approaches, data‑driven oversight, and continuous improvement—ultimately ensuring high‑performing sites, reliable data, and positive investigator relationships across Ipsen’s global portfolio.
Main Responsibilities & Technical Competencies
Trial Delivery
- Establish partnerships with FSP provider(s) to ensure delivery of the IPSEN portfolio of work.
- Partner with functional leaders and FSP partners to ensure clinical trials are delivered on time, within budget, and in-line with Quality standards.
- Overall accountability 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 are bringing the right resource on board to ensure overall delivery.
- Drive continuous improvement of Clinical Operations processes and procedures to optimise development speed, quality, quality and regulatory compliance.
Strategic Leadership & Operating Model Definition
- Define, in collaboration with the CDO LT, Ipsen’s global Study, Site Management and Monitoring strategy aligned with the broader CDO FSP operating model and enterprise clinical development objectives.
- Lead the design, implementation, and ongoing optimization of Ipsen’s FSP‑based Country Operations and Monitoring model.
- Serve as the accountable business owner for all country/site‑level operational processes, ensuring clarity of roles between Ipsen and FSP partners.
- Translate clinical portfolio needs into scalable, sustainable Study, Site Management and Monitoring solutions across therapeutic areas and regions.
- Contribute to CDO and clinical development governance forums, representing site‑level execution, risks, and performance trends.
- Contribute as a member of the CDO leadership team, supporting strategic planning, budget management, external environment influencing etc.
Functional Service Provider (FSP) Oversight & Governance
- Provide end‑to‑end oversight of FSP partners delivering:
- Country feasibility and site identification
- Site selection and initiation
- Study start‑up activities (including regulatory and contractual interfaces)
- Recruitment to agreed targets.
- Study, Site Management and Monitoring.
- Study close‑out and inspection readiness activities.
- Cross country and in country Study Management
- Collaborate with CDO (e.g. Partnerships Team) and global partners (e.g. Procurement) to define and maintain clear governance structures, including KPIs, SLAs, escalation pathways, and performance standards.
- Define and create, in collaboration (e.g. with Business Enablement and Compliance), a clear Study/Study, Site Management and Monitoring Process Framework.
- Ensure consistent application of Ipsen standards, SOPs, and quality expectations across all FSP‑delivered activities.
- Drive a strong partnership culture with FSP providers while maintaining appropriate independence and sponsor oversight.
- Lead escalation and remediation of performance, quality, or compliance issues related to country or site‑level execution.
Country Feasibility, Site Selection & Start ‑ Up Oversight
- In collaboration with appropriate global functions, establish standardized, data‑driven approaches to country feasibility and site selection, ensuring optimal country and site choices.
- Oversee site feasibility execution and validation to support realistic enrolment projections and operational planning.
- Ensure efficient, compliant study start‑up execution, including:
- Site contracting and budget negotiations.
- Regulatory and ethics submissions (in partnership with Regulatory/Start‑Up teams).
- Site initiation readiness.
- Monitor start‑up performance metrics and proactively address delays or bottlenecks.
Site Management & Monitoring Excellence
Partner (e.g. with Data Management & Central Monitoring) on the implementation of risk‑based monitoring (RBQM) strategies in line with regulatory expectations and Ipsen standards. Ensure effective monitoring delivery across studies, including:
- On‑site, remote, and centralized monitoring activities
- Investigational product compliance oversight
- Source data verification, source document review and data quality oversight.
Partner with Data Management, Biostatistics, and Central Monitoring functions to ensure integrated oversight and risk mitigation. Drive consistency in site execution, issue management, and protocol adherence across all regions and studies.
Study Close ‑ Out & Inspection Readiness
Ensure timely and compliant study and site close‑out activities across Ipsen’s portfolio. Maintain continuous inspection readiness at site and country level, including oversight of:
- TMF completeness and quality (in collaboration with TMF leadership)
- Site documentation and essential document quality
- Inspection preparedness activities with FSP partners and internal stakeholders
- Support regulatory inspections and audits, acting as a senior sponsor representative for Study, Site Management and Monitoring matters.
Site Engagement Strategy
Define and own Ipsen’s global Site Engagement Strategy, aligned to clinical development priorities, therapeutic focus, and portfolio growth. Establish a structured approach to understanding Ipsen’s site landscape using which to lead the identification of priority and strategic sites, differentiating:
- Key global and regional strategic partners
- High‑performing operational delivery sites.
- Emerging or development sites critical to pipeline growth
Partner with key stakeholders (e.g. Medical) to ensure that a robust, differentiated site engagement strategy is put into place.
IPSEN Team Leadership
Define, build, and grow the IPSEN internal Study, Study, Site Management and Monitoring organisation. Overseeing the team of internal Clinical Trial Managers (CTMs) who will be responsible for Study Management within a cluster of countries and the Sr Clinical Research Associates. Partner with appropriate groups e.g. Training to ensure a highly skilled team focused on delivery.
Quality, Compliance & Risk Management
Ensure all Study, Site Management and Monitoring activities comply with:
- ICH‑GCP
- Applicable regional and local regulations
- Ipsen SOPs, policies, and quality standards
Embed proactive risk identification and mitigation at site and country level. Collaborate closely with Quality Assurance to address audit findings, CAPAs, and continuous improvement initiatives. Promote a culture of quality, accountability, and patient safety across internal teams and FSP partners.
Performance Management, Metrics & Continuous Improvement
Define and oversee a robust performance management framework for Study, Site Management and Monitoring activities.
Leverage operational, quality, and performance data to:
- Identify trends and risks.
- Drive evidence‑based decision‑making.
- Continuously improve efficiency and quality.
Partner with Strategy and Operations and Business Enablement teams to enhance reporting and oversight capabilities (e.g. dashboards, KPIs). Champion innovation, digital enablement, and simplification across site‑level processes where appropriate.
Leadership, Stakeholder Management & Culture
Lead and develop high‑performing internal teams and matrixed functions supporting Study, Site Management and Monitoring.
Act as a key interface with senior stakeholders across Clinical Development, Quality, Regulatory, Medical, and Global Operations. Represent Ipsen externally with investigators, partners, and vendors as required. Foster a culture of collaboration, accountability, and continuous learning across Ipsen and its partner ecosystem.
Knowledge & Experience
- 15+ years’ experience within pharmaceutical/biotech or related industry with track record of transformational leadership across a global cross-functional working environment.
- 15+ years of experience leading Country Operations teams of different sizes and operational models across all trial types (including Early Development).
- 15+ years’ people/project management experience, (e.g., leading project teams, operational teams, cross functional teams through operational change and transformation).
- Extensive experience in clinical development, clinical operations, quality, compliance, or related areas in the pharmaceutical or biotech industry.
- Deep understanding of the clinical trial landscape and commitment to innovation, creativity, and operational excellence.
- Extensive, demonstrated, knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations.
- Experience in audit/inspection readiness, preparation and conduct. Track record of managing FDA/EMA inspections.
- Demonstrated ability to provide visionary and strategic leadership is required.
- Experience in large-scale organisational change management/implementation programs.
- Proven influencer and change agent with superior project management capabilities. Project management excellence in planning, prioritisation, problem solving and organisational skills. Used to managing multiple priorities in a dynamic environment. Agile mind-set.
- Experience in managing internal stakeholders and used to communicating across all levels of the organization including up to ELT level.
- Extensive knowledge of Good Clinical Practice and related global regulatory and compliance requirements for clinical studies.
- Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness in changing environment is required
- Sound financial acumen is required
Education / Certifications (essential):
- A minimum of a bachelor’s degree (University/college degree) in a scientific discipline or general management is required.
Education / Certifications (preferred):
- Advanced degree (e.g., Masters, MBA, MD, PhD) is highly preferred.
Language(s) (essential):
English
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