12 set
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Recordati
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Milano
ppAt 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. /ppWhat 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. Our values – Better Together, Never Settle and Always Deliver – reflect this mindset, helping us to keep improving and make a meaningful difference. /ppAbove 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. /ppAre you ready to unlock your full potential? /ph3Job Purpose /h3pThe 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. /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 Oversight /li /ulpOversight of site and country performance and CRO in field activities as Sponsor representative. /pulliGCP Regulatory Compliance /li /ulpSolid knowledge of ICH GCP and applicable local and international regulations. /pulliSite Investigator Engagement /li /ulpAbility to establish trusted, productive relationships with PIs and site teams, facilitating scientific and operational discussions. /pulliCRO CRA Oversight /li /ulpOversight of CRA activities, identification of site level risks, and escalation to regional/Lead CSMs. /pulliRecruitment Performance Optimisation /li /ulpIdentification of recruitment barriers and contribution to enrolment acceleration strategies. /pulliCross functional Clinical Operations Knowledge /li /ulpUnderstanding of the full clinical trial lifecycle, from feasibility to close out. /pulliClinical Systems Tools Literacy /li /ulpWorking knowledge of CTMS, eTMF, EDC and MS Office tools to support effective oversight. /ph3Required Behaviours And Competencies /h3ulliStakeholder Relationship Management /li /ulpBuilds strong, trust based relationships internally and externally as Recordati’s primary field representative. /pulliProactive Risk Issue Management /li /ulpAnticipates risks, escalates issues early and supports timely resolution. /pulliEffective Communication Influence /li /ulpCommunicates clearly, consistently and with impact across sites and internal teams. /pulliAccountability Ownership /li /ulpDemonstrates strong ownership of site performance, follow up and closure of actions. /pulliCollaboration Role Clarity /li /ulpWorks in close partnership with Clinical Study Managers, respecting role boundaries. /pulliProblem Solving Solution Orientation /li /ulpApplies a pragmatic, solution focused mindset to operational and site challenges. /ph3Required Languages /h3pFluent written and spoken English, Italian and another European language /ph3Travel required in % /h3pApproximately 60% domestic and international travel, with the role based in Milan; travel frequency may vary depending on study requirements and operational needs. /ppCandidates must hold the right to work in the hiring country /ppAt Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. /ppWe are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. /p /p #J-18808-Ljbffr
📌 Clinical Trial Liaison Manager (Milano)
🏢 Recordati
📍 Milano