Clinical Trial Liaison Manager

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Job Description Summary

The 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.

Job Description

The 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.

Key Responsibilities

• Acts 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.
• Drives enrolment at the Principal Investigator level mainly and works closely with CRAs and Site Coordinators to ensure they understand the PI’s enrolment strategy.
• In 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.
• Oversees and tracks patient recruitment for sites and pro-actively identify ways to prevent recruitment delays.
• Ensures data quality and data integrity meet GCP and local regulations, through data review (remote and onsite).
• Oversees the activities of local CRO teams to ensure effective Sponsor oversight of monitoring activities and adherence to study processes.
• Provides support to CRAs and other local CRO team members, to support trial delivery and compliance, where necessary.
• May attend PSVs, SIVs, IMVs, COVs, as required and defined in collaboration with Lead CSM.
• Conducts 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.
• Conduct motivational / booster Visits when requested.
• Pro-actively identify issues and look for solutions in the assigned clinical trial and timely elevate them to the Lead CSM.
• Aligns and leads identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution.
• Accountable for strategic long-term operational partnerships with key sites, provide local intelligence.
• May work across trials in the same or similar therapeutic areas within the same region.

Other Skills And Responsibilities

• May support the development of recruitment and retention plans, in collaboration with Lead CSM.
• Reports 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.
• Feeds information and provides possible solutions up to the Lead CSM on site performance and risks.
• Proactively 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.
• Proactively resolves issues and also appropriately and timely escalates issues where necessary.
• Collaborates with other CTLMs and Lead CSM to share beneficial experiences and best practices.
• May be asked to attend Audit/Inspections.
• May work with QA, assisting with audit and inspection preparations and follow-up, including the generation and implementation of CAPA plans.
• Travel required in % Approximately 60% (national and international travel)

Technical Competences & Soft Skills

• Fluency in Polish and English, Italian is a plus.
• Proven ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Self-starter who thrives in a collaborative, yet less structured team environment
• Ability to problem-solve unstructured or ambiguous challenges
• Strong command of English, both written and verbal
• Excellent communication and interpersonal skills with customer service orientation
• Proficient with MS Office Suite, particularly Word and Excel

Languages

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

Contract Type

Outsourced Service Provider

Salary Range

The 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.