ppAre you being referred to one of our roles by a connection in Alira Health? Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /p h3Job Description Summary /h3 pThe Clinical Trial Liaison Manager is a field-based country(ies)/regional role, responsible for the oversight of sites and country(ies) trial delivery and performance in terms of subject recruitment, adherence to protocol and regulations and timely delivery of high-quality data. The CTLM is the ‘face of’ Sponsor for site relations and engagement, supporting study teams with startup and recruitment, and oversees in-field activities of the contracted CRO for a study, focused on the CRAs team as part of trial Sponsor oversight of outsourced trial responsibilities. The CTLM also serve as a site escalation point for investigator concerns, including issues which are unresolved by the CRO, so that these may be communicated to the appropriate Sponsor responsible party. The CTLM will also establish engagement at the Principal Investigator level to discuss overall study updates, recruitment plans and to facilitate any scientific questions the PI may have during the study and ensure a strong relationship between Sponsor and site. The CTLM additionally provides direct support to local site staff, CRO CRAs and other trial team members within the assigned country(ies)/region as required to enable successful trial conduct. The role interacts with cross-functional project teams, ensuring adherence to project plans, applicable regulatory, GCP and SOP requirements and company policies and procedures. /p h3Job Description /h3 pThe Clinical Trial Liaison Manager is a field-based country(ies)/regional role, responsible for the oversight of sites and country(ies) trial delivery and performance in terms of subject recruitment, adherence to protocol and regulations and timely delivery of high-quality data. The CTLM is the ‘face of’ Sponsor for site relations and engagement, supporting study teams with startup and recruitment, and oversees in-field activities of the contracted CRO for a study, focused on the CRAs team as part of trial Sponsor oversight of outsourced trial responsibilities. The CTLM also serve as a site escalation point for investigator concerns, including issues which are unresolved by the CRO, so that these may be communicated to the appropriate Sponsor responsible party.



The CTLM will also establish engagement at the Principal Investigator level to discuss overall study updates, recruitment plans and to facilitate any scientific questions the PI may have during the study and ensure a strong relationship between Sponsor and site. The CTLM additionally provides direct support to local site staff, CRO CRAs and other trial team members within the assigned country(ies)/region as required to enable successful trial conduct. The role interacts with cross-functional project teams, ensuring adherence to project plans, applicable regulatory, GCP and SOP requirements and company policies and procedures. /p h3Key Responsibilities /h3 ul liActs as an ambassador for Sponsor supporting its positioning as a sponsor of choice, sponsor ‘face’ with the Investigator and site staff. The CTLM has a broad knowledge of the company strategy and pipeline potential. /li liDrives enrolment at the Principal Investigator level mainly and works closely with CRAs and Site Coordinators to ensure they understand the PI’s enrolment strategy. /li liIn conjunction with Investigators and CRAs, works to facilitate collaboration between different departments or groups within the same trial site to optimise the enrolment of trial subjects. /li liOversees and tracks patient recruitment for sites and pro-actively identify ways to prevent recruitment delays. /li liEnsures data quality and data integrity meet GCP and local regulations, through data review (remote and onsite). /li liOversees the activities of local CRO teams to ensure effective Sponsor oversight of monitoring activities and adherence to study processes. /li liProvides support to CRAs and other local CRO team members, to support trial delivery and compliance, where necessary. /li liMay attend PSVs, SIVs, IMVs, COVs, as required and defined in collaboration with Lead CSM. /li liConducts Sponsor Oversight Monitoring Visits (SOVs) to ensure accurate and compliant monitoring (e.g. SDR, SDV) by the CRO and study progress visits to trial sites. Source data verification activity may be requested at site from CTLM during SOVs. /li liConduct motivational / booster Visits when requested. /li liPro-actively identify issues and look for solutions in the assigned clinical trial and timely elevate them to the Lead CSM.



/li liAligns and leads identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution. /li liAccountable for strategic long-term operational partnerships with key sites, provide local intelligence. /li liMay work across trials in the same or similar therapeutic areas within the same region. /li /ul h3Other Skills And Responsibilities /h3 ul liMay support the development of recruitment and retention plans, in collaboration with Lead CSM. /li liReports the local situation at the site to the Lead CSM, including opinions and observations related to the operational, scientific and any other aspects of the trial. /li liFeeds information and provides possible solutions up to the Lead CSM on site performance and risks. /liliProactively facilitates the resolution of challenges that the sites are facing, such as recruitment issues and quality issues, which are tailored specifically to the local situation. /li liProactively resolves issues and also appropriately and timely escalates issues where necessary. /li liCollaborates with other CTLMs and Lead CSM to share beneficial experiences and best practices. /li liMay be asked to attend Audit/Inspections. /li liMay work with QA, assisting with audit and inspection preparations and follow-up, including the generation and implementation of CAPA plans. /li liTravel required in % Approximately 60% (national and international travel) /li /ul h3Technical Competences Soft Skills /h3 ul liFluency in Polish and English, Italian is a plus. /li liProven ability to be careful, thorough, and detail-oriented /li liStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environment /li liStrong analytical, negotiation, meeting management, cross-functional team, and leadership skills /li liSelf-starter who thrives in a collaborative, yet less structured team environment /li liAbility to problem-solve unstructured or ambiguous challenges /li liStrong command of English, both written and verbal /li liExcellent communication and interpersonal skills with customer service orientation /li liProficient with MS Office Suite, particularly Word and Excel /li /ul h3Languages /h3 pEnglish /p h3Education /h3 pBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy /p h3Contract Type /h3 pOutsourced Service Provider /p h3Salary Range /h3 pThe final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. /p /p #J-18808-Ljbffr

📌 Clinical Trial Liaison Manager (Milano)
🏢 Alira Health
📍 Milano