Clinical Trial Liaison Associate Director

Benefits

Qualifications

• •Proven track record of managing long-term professional relationships (e.g. Clinical sites)
• •Must have good working knowledge of ICH FDA EU-CTR IRB/IEC and other applicable regulations/guidelines and significant experience with Clinical Site start-up documents
• •Fluency in English
• •Bachelors degree
• •Requires 8 years of experience in Clinical Development or the equivalent combination of education and experience
• •Hybrid: work remotely up to two days per week; or select
• •Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
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Responsibilities

• •Vertex has established the Clinical Trial Liaison (CTL) role that transforms the Clinical Research site experience with Vertex by making the customer experience a priority
• •This is a strategic role that acts as a critical interface between Vertex and Clinical Research sites primarily for therapeutic area networking and site outreach education specialized trainings and enrollment accelerations
• •Reporting to the Director GCO Patient and Site Engagement the CTL/Associate Director must have an in-depth understanding of clinical research and associated regulatory requirements in the region and provide team leadership and/or specific operational & expertise in multiple therapeutic areas
• •Serve as a professional competent and reputable Vertex representative in direct interaction with clinical trial investigators academic institutions and therapeutic area networks related to studies in feasibility and site selection and conduct routine visits during the life of a study
• •Identify new sites for consideration conducting therapeutic area network and site outreach and influence Vertex culture about clinical research
• •Include focus on diverse investigators in underrepresented communities
• •Identify opportunities for process improvements to achieve better results in study execution and feedback information to the functions and study teams
• •Key decision maker in country/site selection activities representing regional insight and interests in collaboration with Medical Affairs including new sites and new regions
• •Participation in Clinical Trial Allocation Committee meetings
• •Understand the scientific aspects of a protocol that will help with site engagement indication investigation determining the key eligibility criteria for trail subjects ensuring trial success at participating sites
• •Support site training through discussions of the investigational product and provide the rational for study design and key eligibility criteria in collaboration with Clinical Development
• •Conduct specialized trainings
• •Can provide additional support to prioritized programs as needed
• •Define monitor and report Key Performance Indicators (KPIs) for site performance
• •Stay abreast of regulations and industry trends and proactively prepare to maintain compliance
• •Leverage in-depth understanding of local regulations and trial implementation pathways to ensure streamlined site start-up
• •Take on a Disease Area Lead role to streamline communication between project teams and CTLs
• •Provide input into the development of feasibility questionnaires
• •Develop and manage relationships with external site and therapeutic area networks
• •Travel may be required up to 50% of time
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