Clinical Trial Manager (m/f/d)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cxo41

Job PurposeThe Clinical Trial Liaison Manager (CTLM) is responsible for site performance, trial delivery and Sponsor oversight across assigned countries.

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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.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.• 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).• 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.• 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.• 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.

• Experience with clinical trial systems and tools (e.g.

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.• 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.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. xysqume • Collaboration & Role ClarityWorks in close partnership with Clinical Study Managers, respecting role boundaries.• 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;

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cxo41