11 ago - Milano
EUSA Pharma
Job PurposeThe Clinical Trial Liaison Manager (CTLM) is responsible for site performance, trial delivery and Sponsor oversight across assigned countries. The CTLM ensures timely, high‑quality clinical trial execution, with a strong focus on patient recruitment, protocol adherence, regulatory compliance, and data quality.Acting as the primary Sponsor representative (“face of Recordati”) at site level, the CTLM builds and maintains strong relationships with Principal Investigators (PIs) and site teams, supports study start‑up and recruitment, and provides in‑field oversight of CRO activities—particularly CRA performance—as part of Recordati’s Sponsor oversight responsibilities.The CTLM serves as a key escalation point for site and investigator issues, including unresolved CRO matters, ensuring timely communication to the appropriate Recordati stakeholders. The role provides hands‑on operational and engagement support to sites, CRO CRAs and trial teams to enable successful trial conduct and sustained site performance.Working in close collaboration with cross‑functional project teams, the CTLM ensures adherence to project plans, GCP, regulatory requirements, SOPs and company policies, contributing to Recordati’s positioning as a Sponsor of choice.Key ResponsibilitiesSite Performance & Recruitment• Acts as Recordati’s Sponsor ambassador at site level, fostering long term, trust based relationships with PIs and site staff.• Drives patient recruitment by engaging directly with PIs, understanding site specific enrolment strategies, and supporting recruitment acceleration initiatives.• Works closely with CRAs and site coordinators to ensure alignment on enrolment plans and site priorities.• Facilitates collaboration across departments within trial sites to optimise patient identification and enrolment.• Proactively monitors recruitment metrics and identifies and mitigates risks to enrolment timelines.Sponsor & CRO Oversight• Provides Sponsor oversight of CRO monitoring activities, with a particular focus on CRA performance and adherence to study processes.• Conducts Sponsor Oversight Visits (SOVs) and study progress visits to ensure compliant, high quality monitoring (e.g. SDV, issue management).• May attend PSVs, SIVs, IMVs and COVs,
as defined in collaboration with the Lead Clinical Study Manager (CSM).• Conducts motivational / booster visits when required to re energise site engagement and performance.Quality, Compliance & Issue Management• Ensures data quality and data integrity through on site and remote data review, in compliance with ICH GCP and local regulations.• Proactively identifies operational and site level issues, driving timely resolution and escalating risks to the Lead CSM as appropriate.• Serves as a site escalation point for investigator concerns, ensuring effective Sponsor follow up and resolution.• Maintains accountability for long term site partnerships, providing local intelligence and insights to the study team.Communication & Cross functional Collaboration• Establishes regular engagement with PIs to discuss study progress, recruitment plans, and scientific or operational questions.• Reports site status, performance insights, risks and mitigation strategies to the Lead CSM.• Works across multiple trials within the assigned region, as required, ensuring consistent Sponsor presence and oversight.Required EducationBachelor’s degree (or international equivalent) in pharmaceutical sciences, chemistry, biology, medicine, healthcare or a related scientific disciplineRequired Skills and Experience• Minimum 6 years’ experience in Pharma/Biotech, preferably in roles involving clinical site monitoring, site oversight or site engagement. • Strong understanding of the healthcare and therapeutic landscape, patient pathways and investigative site operations. • Proven ability to build and manage relationships with PIs, site staff, CROs and internal stakeholders. • Demonstrated proactive leadership, with the ability to influence without authority and remove operational barriers. • Highly developed organisational, analytical and problem solving skills,
with strong prioritisation capability. • Experience with clinical trial systems and tools (e.g. CTMS, eTMF, EDC). • Experience in global clinical trials; rare disease experience is a strong advantage. • Valid driver’s licence.Technical Competencies• Clinical Trial & Sponsor OversightOversight of site and country performance and CRO in field activities as Sponsor representative.• GCP & Regulatory ComplianceSolid knowledge of ICH GCP and applicable local and international regulations.• Site & Investigator EngagementAbility to establish trusted, productive relationships with PIs and site teams, facilitating scientific and operational discussions.• CRO & CRA OversightOversight of CRA activities, identification of site level risks, and escalation to regional/Lead CSMs.• Recruitment & Performance OptimisationIdentification of recruitment barriers and contribution to enrolment acceleration strategies.• Cross functional Clinical Operations KnowledgeUnderstanding of the full clinical trial lifecycle, from feasibility to close out.• Clinical Systems & Tools LiteracyWorking knowledge of CTMS, eTMF, EDC and MS Office tools to support effective oversight.Required Behaviours and Competencies• Stakeholder & Relationship ManagementBuilds strong, trust based relationships internally and externally as Recordati’s primary field representative.• Proactive Risk & Issue ManagementAnticipates risks, escalates issues early and supports timely resolution.• Effective Communication & InfluenceCommunicates clearly, consistently and with impact across sites and internal teams.• Accountability & OwnershipDemonstrates strong ownership of site performance, follow up and closure of actions.• Collaboration & Role ClarityWorks in close partnership with Clinical Study Managers, respecting role boundaries.• Problem Solving & Solution OrientationApplies a pragmatic, solution focused mindset to operational and site challenges.Required LanguagesFluent written and spoken English, Italian and another European languageTravel required in %Approximately 60% domestic and international travel, with the role based in Milan; travel frequency may vary depending on study requirements and operational needs.Candidates must hold the right to work in the hiring country
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