14 set
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Recordati
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Milano
At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do. What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution. The 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. 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. 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 Reports site status, performance insights, risks and mitigation strategies to the Lead CSM. Bachelor’s degree (or international equivalent) in pharmaceutical sciences, chemistry, biology, medicine,
healthcare or a related scientific discipline Required 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. Clinical Trial & Sponsor Oversight Oversight of site and country performance and CRO in field activities as Sponsor representative. ~ GCP & Regulatory Compliance Solid knowledge of ICH GCP and applicable local and international regulations. ~ Ability to establish trusted, productive relationships with PIs and site teams, facilitating scientific and operational discussions. ~ CRO & CRA Oversight Oversight of CRA activities, identification of site level risks, and escalation to regional/Lead CSMs. ~ Cross functional Clinical Operations Knowledge Understanding of the full clinical trial lifecycle, from feasibility to close out. ~ Clinical Systems & Tools Literacy Working knowledge of CTMS, eTMF, EDC and MS Office tools to support effective oversight. Stakeholder & Relationship Management Proactive Risk & Issue Management Anticipates risks, escalates issues early and supports timely resolution. ~ Communicates clearly, consistently and with impact across sites and internal teams. ~ Collaboration & Role Clarity Works in close partnership with Clinical Study Managers, respecting role boundaries. ~ Required Languages Fluent written and spoken English, Italian and another European language Approximately 60% domestic and international travel, with the role based in Milan ; If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
📌 Clinical Study Manager (w/m) (Milano)
🏢 Recordati
📍 Milano