Clinical Research Associate (Ass. Site Manager)

Johnson & Johnson

  • Breda, Noord-Brabant
  • Vast
  • Voltijds
  • 14 dagen geleden
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: R&D OperationsJob Sub Function: Clinical Trial SupportJob Category: ProfessionalAll Job Posting Locations: Breda, NetherlandsJob Description:We are looking for a driven Associate Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 1b, 2 & 3 in the Netherlands and in Belgium. As Associate Site Manager, you have to ensure inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure. We need a flexible Site Manager who is able to work independently, is a real teammate, a quick learner, a problem solver, and a good communicator. You will collaborate with a Local Trial Manager (LTM), a Clinical Trial Assistant (CTA), and a Trial Delivery Manager (TDM) to perform trial-related activities for assigned protocols and sites and you are responsible for the overall site management activities. You will be part of a hardworking, enthusiastic, and committed team of +100 people eager to deliver and helping to improve the lives of millions of patients!Principal Responsibilities:
  • Responsible for activities ranging from site initiation and start-up, over preparation and conduct of site monitoring, oversight of key performance indicators to site/study close-out.
  • Responsible for the implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits.
  • Contributing to site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
  • Attends regularly scheduled team meetings and training.
  • May participate to process improvement and training.
Education and Experience Requirements:
  • BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
  • Previous clinical trial monitoring experience (1year) is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
  • Strong proven understanding of GCP, local laws, and regulations
  • Strong IT skills in appropriate software and company systems
  • Willingness to travel with occasional overnight stay away from home
  • Drivers license B required
  • Proficient in Dutch and English
  • Team player
This position is to be located in Breda, Netherlands and requires one day office presence per week.

Johnson & Johnson