Regional Site Advocate-
Sydney, Australia
2d ago

Job Description

Vertex is seeking to establish a new role to transform the Clinical Research site experience with Vertex by making the customer experience a priority.

Vertex is hiring Regional Site Advocates (RSA) in the US, EU and Australia.This is a strategic role that acts as a critical interface between Vertex and Clinical Research sites for all operational issues.

Reporting to the Sr.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

  • Bachelor’s degree with a major in a related field and many 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
  • Experience in Cystic Fibrosis is preferred
  • 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
  • Company Information

    Vertex is a global biotechnology company that invests in scientific innovation.

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