Clinical Research Manager

hace 4 semanas


Ciudad de México, Ciudad de México PSI A tiempo completo

Job Title: Lead CRA

About the Role

We are seeking a highly skilled and experienced Lead Clinical Research Associate to join our team at PSI. As a Lead CRA, you will play a key role in managing local Monitors, supervising clinical monitoring and site management activities to ensure the protection of trial subjects' rights, safety, and well-being, data quality, and study compliance on a country/regional level.

Key Responsibilities

  • Facilitate regional projects as Lead Monitor and supervise study activities, timelines, and schedules.
  • Train Monitors in annotated monitoring visit reports.
  • Review monitoring reports and support monitors in their activities.
  • Act as the main communication line between Monitor and Regional Lead.
  • Facilitate site budgets and contract negotiations.
  • Be a point of contact for in-house support services and vendors.
  • Communicate with internal project teams regarding study progress and lead project team calls on the country level.
  • Participate in quality control and compliance monitoring.
  • May need to monitor and manage sites (if applicable).
  • May need to supervise monitors on site.
  • Oversee and maintain study-specific and corporate tracking systems at site and country level.

Requirements

  • College/University degree in Life Sciences, Pharmacy, RN, or an equivalent combination of education, training, and experience.
  • Participation in clinical projects as a Lead/Senior Monitor.
  • At least 4 years of experience as Senior CRA.
  • Independent on-site monitoring experience.
  • Full working proficiency in English and Spanish.
  • PC skills to be able to work with MS Word, Excel, and PowerPoint.
  • Ability to plan, multitask, and work in a dynamic team environment.
  • Communication, leadership, and problem-solving skills.
  • Ability to travel.

What We Offer

At PSI, we offer a dynamic and supportive work environment that allows our employees to grow and develop their careers. As a Lead CRA, you will have the opportunity to work closely with driven and dedicated cross-functional teams, receive all the support and ownership of your projects, and advance your career in clinical research.


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