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Regional Site Advocate

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

This is a strategic role that acts as a critical interface between Vertex and Clinical Research sites for all operational issues. Reporting to the Director, Clinical Development Execution, the Site Advocate must have an in-depth understanding of clinical research and associated regulatory requirements in the region.

Key Responsibilities :

* Serve as a professional, competent and reputable Vertex representative in direct interaction with clinical trial investigators and academic institutions on all activities related to study execution * Dedicated to serving as the key point of contact for sites for any operational issues that are not rapidly resolved through established pathways * Establish continuity for sites involved in multiple studies/programs * Navigate within Vertex and vendors to identify root cause and to expedite resolution of the issues * Actively develop and maintain positive working relationships with Clinical Research site personnel; conduct routine and as needed site visits * Identify opportunities for process improvements to achieve better results in study execution * Key decision maker in country/site selection activities, representing regional insight and interests in collaboration with Medical Affairs * Lead Vertex study team to achieve recruitment and study execution goals * Partner with the Medical Science Liaison, identify new sites and assess capabilities for participation in Vertex clinical studies * Ensure training new sites on Vertex protocols/processes/systems, potentially including GCP training for research naive sites * Anticipate and escalate site specific challenges and requirements and proactively communicate to the team to plan and mitigate risks * Develop knowledge repository for site /country specific information related to study execution * Define, monitor and report Key Performance Indicators (KPIs) for site performancePartner with other RSAs globally to achieve industry leading 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 * Ensure seamless internal communication between Clinical Development and Regional Medical Affairs Team

This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned. Travel may be required up to 50% of time.

Minimum Qualifications

* Bachelors degree with a major in a related field and at least 8 years of Clinical Development experience * Proven track record of management of long-term professional relationships (e. g. Clinical sites) * Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and significant experience with Clinical Site start-up documents * Medical background or experience in Vertex Therapeutic Areas a plus

Preferred Qualifications:

* Outstanding collaboration skills * Self-motivated and ability to work well independently and in a team environment * Excellent verbal and written communication * Excellent critical thinking and problem solving skills

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Regional Site Advocate, Other , Boston, Massachusetts

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