31 lug - Turbigo
Recordati
ph3Job Purpose /h3 pThe 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. /p h3Key Responsibilities /h3 h3Site Performance Recruitment /h3 ul liActs as Recordati’s Sponsor ambassador at site level, fostering long‑term, trust‑based relationships with PIs and site staff. /li liDrives patient recruitment by engaging directly with PIs, understanding site‑specific enrolment strategies, and supporting recruitment acceleration initiatives. /li liWorks closely with CRAs and site coordinators to ensure alignment on enrolment plans and site priorities. /li liFacilitates collaboration across departments within trial sites to optimise patient identification and enrolment. /li liProactively monitors recruitment metrics and identifies and mitigates risks to enrolment timelines. /li /ul h3Sponsor CRO Oversight /h3 ul liProvides Sponsor oversight of CRO monitoring activities, with a particular focus on CRA performance and adherence to study processes. /li liConducts Sponsor Oversight Visits (SOVs) and study progress visits to ensure compliant, high‑quality monitoring (e.g., SDV, issue management). /li liMay attend PSVs, SIVs, IMVs and COVs, as defined in collaboration with the Lead Clinical Study Manager (CSM).
/li liConducts motivational / booster visits when required to re‑energise site engagement and performance. /li /ul h3Quality, Compliance Issue Management /h3 ul liEnsures data quality and data integrity through on‑site and remote data review, in compliance with ICH GCP and local regulations. /li liProactively identifies operational and site‑level issues, driving timely resolution and escalating risks to the Lead CSM as appropriate. /li liServes as a site escalation point for investigator concerns, ensuring effective Sponsor follow‑up and resolution. /li liMaintains accountability for long‑term site partnerships, providing local intelligence and insights to the study team. /li /ul h3Communication Cross‑Functional Collaboration /h3 ul liEstablishes regular engagement with PIs to discuss study progress, recruitment plans, and scientific or operational questions. /li liReports site status, performance insights, risks and mitigation strategies to the Lead CSM. /li liWorks across multiple trials within the assigned region, as required, ensuring consistent Sponsor presence and oversight. /li /ul h3Required Education /h3 pBachelor’s degree (or international equivalent) in pharmaceutical sciences, chemistry, biology, medicine, healthcare or a related scientific discipline. /p h3Required Skills And Experience /h3 ul liMinimum 6 years’ experience in Pharma/Biotech, preferably in roles involving clinical site monitoring, site oversight or site engagement. /li liStrong understanding of the healthcare and therapeutic landscape, patient pathways and investigative site operations. /li liProven ability to build and manage relationships with PIs, site staff, CROs and internal stakeholders. /li liDemonstrated proactive leadership, with the ability to influence without authority and remove operational barriers. /li liHighly developed organisational, analytical and problem‑solving skills, with strong prioritisation capability. /li liExperience with clinical trial systems and tools (e.g., CTMS, eTMF, EDC).
/li liExperience in global clinical trials; rare disease experience is a strong advantage. /li liValid driver’s licence. /li /ul h3Technical Competencies /h3 ul liOversight of site and country performance and CRO in‑field activities as Sponsor representative. /li liSolid knowledge of ICH GCP and applicable local and international regulations. /li liAbility to establish trusted, productive relationships with PIs and site teams, facilitating scientific and operational discussions. /li liOversight of CRA activities, identification of site level risks, and escalation to regional/Lead CSMs. /li liIdentification of recruitment barriers and contribution to enrolment acceleration strategies. /li liUnderstanding of the full clinical trial lifecycle, from feasibility to close‑out. /li liWorking knowledge of CTMS, eTMF, EDC and MS Office tools to support effective oversight. /li /ul h3Required Behaviours And Competencies /h3 ul liBuilds strong, trust‑based relationships internally and externally as Recordati’s primary field representative. /li liAnticipates risks, escalates issues early and supports timely resolution. /li liCommunicates clearly, consistently and with impact across sites and internal teams. /li liDemonstrates strong ownership of site performance, follow‑up and closure of actions. /li liWorks in close partnership with Clinical Study Managers, respecting role boundaries. /li liApplies a pragmatic, solution‑focused mindset to operational and site challenges. /li /ul h3Required Languages /h3 pFluent written and spoken English, Italian and another European language. /p h3Travel required /h3 pApproximately 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. /p h3Equal Opportunity EEO Statement /h3 pAt Recordati we believe in people! 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. We are proud to be an equal‑opportunity employer. We recruit, develop and reward without regard to, among 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
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