Clinical Trial Manager

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Job Description
SummaryThe 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 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 proceduresJob DescriptionROLEThe 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 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 proceduresKey

Responsibilities:
Contributes to operational trial deliverables at clinical trial sites according to timelines, budget, operational procedures, quality/compliance, and performance standards. Assigned

key responsibilities
can include (but are not limited to): Acts as an ambassador for Sponsor supporting its positioning as a sponsor of choice, sponsor 'face' with the Investigator and site staff. 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. 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. Source data verification activity may be requested at site from CTLM during SOVs. Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate 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 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,