Clinical Trial Liaison Manager

Are 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.

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…