ph3Descrizione dell’offerta di lavoro /h3pJob Purpose: The Clinical Trial Liaison Manager (CTLM) is responsible for site performance, trial delivery and Sponsor oversight across assigned countries. /ppPossiede le competenze, l'esperienza e la determinazione necessarie per avere successo in questo ruolo? Lo scopra qui sotto. /ppThe 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. /ppThe 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. /ph3Key Responsibilities /h3h3Site Performance Recruitment /h3ulliActs as Recordati's Sponsor ambassador at site level, fostering long term, trust based relationships with PIs and site staff. /liliDrives patient recruitment by engaging directly with PIs, understanding site specific enrolment strategies, and supporting recruitment acceleration initiatives. /liliWorks closely with CRAs and site coordinators to ensure alignment on enrolment plans and site priorities. /liliFacilitates collaboration across departments within trial sites to optimise patient identification and enrolment. /liliProactively monitors recruitment metrics and identifies and mitigates risks to enrolment timelines. /li /ulh3Sponsor CRO Oversight /h3ulliProvides Sponsor oversight of CRO monitoring activities, with a particular focus on CRA performance and adherence to study processes. /liliConducts Sponsor Oversight Visits (SOVs) and study progress visits to ensure compliant, high quality monitoring (e.g. SDV, issue management). /liliMay attend PSVs, SIVs, IMVs and COVs, as defined in collaboration with the Lead Clinical Study Manager (CSM). /liliConducts motivational / booster visits when required to re energise site engagement and performance. /li /ulh3Quality, Compliance Issue Management /h3ulliEnsures data quality and data integrity through on site and remote data review, in compliance with ICH GCP and local regulations. /liliProactively identifies operational and site level issues,



driving timely resolution and escalating risks to the Lead CSM as appropriate. /liliServes as a site escalation point for investigator concerns, ensuring effective Sponsor follow up and resolution. /liliMaintains accountability for long term site partnerships, providing local intelligence and insights to the study team. /li /ulh3Communication Cross functional Collaboration /h3ulliEstablishes regular engagement with PIs to discuss study progress, recruitment plans, and scientific or operational questions. /liliReports site status, performance insights, risks and mitigation strategies to the Lead CSM. /liliWorks across multiple trials within the assigned region, as required, ensuring consistent Sponsor presence and oversight. /li /ulh3Required Education /h3pBachelor's degree (or international equivalent) in pharmaceutical sciences, chemistry, biology, medicine, healthcare or a related scientific discipline /ph3Required Skills and Experience /h3ulliMinimum 6 years' experience in Pharma/Biotech, preferably in roles involving clinical site monitoring, site oversight or site engagement. /liliStrong understanding of the healthcare and therapeutic landscape, patient pathways and investigative site operations. /liliProven ability to build and manage relationships with PIs, site staff, CROs and internal stakeholders. /liliDemonstrated proactive leadership, with the ability to influence without authority and remove operational barriers. /liliHighly developed organisational, analytical and problem solving skills, with strong prioritisation capability. /liliExperience with clinical trial systems and tools (e.g. CTMS, eTMF, EDC). /liliExperience in global clinical trials; rare disease experience is a strong advantage. /liliValid driver's licence. /li /ulh3Technical Competencies /h3ulliClinical Trial Sponsor OversightOversight of site and country performance and CRO in field activities as Sponsor representative. /liliGCP Regulatory ComplianceSolid knowledge of ICH GCP and applicable local and international regulations. /liliSite Investigator EngagementAbility to establish trusted, productive relationships with PIs and site teams, facilitating scientific and operational discussions. /liliCRO CRA OversightOversight of CRA activities, identification of site level risks, and escalation to regional/Lead CSMs. /liliRecruitment Performance OptimisationIdentification of recruitment barriers and contribution to enrolment acceleration strategies.



/liliCross functional Clinical Operations KnowledgeUnderstanding of the full clinical trial lifecycle, from feasibility to close out. /liliClinical Systems Tools LiteracyWorking knowledge of CTMS, eTMF, EDC and MS Office tools to support effective oversight. /li /ulh3Required Behaviours and Competencies /h3ulliStakeholder Relationship ManagementBuilds strong, trust based relationships internally and externally as Recordati's primary field representative. /liliProactive Risk Issue ManagementAnticipates risks, escalates issues early and supports timely resolution. /liliEffective Communication InfluenceCommunicates clearly, consistently and with impact across sites and internal teams. /liliAccountability OwnershipDemonstrates strong ownership of site performance, follow up and closure of actions. /liliCollaboration Role ClarityWorks in close partnership with Clinical Study Managers, respecting role boundaries. /liliProblem Solving Solution OrientationApplies a pragmatic, solution focused mindset to operational and site challenges. xlwpduy /li /ulh3Required Languages /h3pFluent written and spoken English, Italian and another European language /ph3Travel /h3pRequired in %Approximately 60% domestic and international travel, with the role based in Milan; travel frequency may vary depending on study requirements and operational needs. /ph3Other /h3pCandidates must hold the right to work in the hiring country /ppAlma Laboris ha avviato il processo di candidatura per i corsi di alta formazione nel settore farmaceutico, offrendo agevolazioni con Placement per favorire lo sviluppo della carriera.L'obiettivo è... /ppQuesta posizione è in Fidia Pharma.Il processo di selezione sarà interamente gestito Fidia Pharma.Questa opportunità è disponibile in Abano terme - Italy, Lazio - Italy, Marche - Italy, Umbria - It... /ppCerchiamo Personal Trainer online per lezioni individuali su Letuelezioni.Non serve esperienza pregressa: contano motivazione, affidabilità e passione.Flessibilità totale e lavoro a distanza.Valutaz... /ppIl nostro cliente è uno dei maggiori attori italiani del settore della consulenza energetica, della sostenibilità ambientale e della decarbonizzazione.Il candidato ideale dovrà possedere l'esperien... /ppArea Manager Freelance per Progetti Innovativi di Efficientamento Energetico.Collaboriamo con aziende di varie dimensioni e settori per implementare progetti su misura che ottimizzino l'uso delle r... /ppX-Pharma Italy, parte del gruppo internazionale X-Pharma Investment SA, è alla ricerca di Informatori Scientifici del Farmaco dinamici e motivati per ampliare la nostra rete di vendita.Se sei un pr... /ppUnisciti a noi come Business Development Manager e diventa parte integrante del nostro team orientato alla crescita nel mercato B2B.Cerchiamo un professionista dinamico e proattivo, capace di costr... /p /p #J-18808-Ljbffr

📌 Clinical Trial Liaison Manager (Spoleto)
🏢 EUSA Pharma
📍 Spoleto