Clinical Trial Liaison Manager
Basel, CH
Job Purpose
The CTLM Clinical Trial Liaison Manager is responsible for the oversight of site and country trial delivery and performance in terms of subject recruitment, adherence to protocol and regulations and timely delivery of high-quality data. The CTLM oversees in-field activities of the contracted CRO for a study, typically focused on the CRA team as part of trial Sponsor oversight of outsourced trial responsibilities. CTLMs additionally provide direct support to local site staff, CRO CRAs and other trial team members within the assigned country(ies) 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 Recordati 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 Coordinator 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).
- 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.
- Maintains accountability for long-term operational partnerships with key sites, providing local intelligence.
- Pro-actively identify issues and look for solutions in the assigned clinical trial and timely escalate them to the Lead CSM, CSM vendor/CRO or Local CSM.
Required Education
Bachelor’s degree (or international equivalent) in pharmaceutical science, chemistry, biology, medical/healthcare or comparable background
Required Skills and Experience
- 4 to 5 years of site monitoring or site oversight responsibilities
- Understand the healthcare therapeutic landscape, patient pathways and investigative sites
- Excellent communication and presentation skills and relationship management of multiple stakeholders, internally and externally, including sites, KOLs, networks, PAGs, CROs and others
- Leadership with the ability to overcome challenges, seek opportunities to remove barriers, influence without authority
- Highly developed organizational skills, problem solving, analytic and able to prioritize
- Experience with tools and systems for managing clinical studies
Technical Competencies
Required Behaviours and Competencies
Required Languages
English, French fluent written and spoken
Any additional language is considered beneficial
Travel required in %
Approximately 60%