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R&D Operations

Senior Clinical Research Associate (Senior Site Manager)

  • Titolo Senior Clinical Research Associate (Senior Site Manager)
  • Funzione R&D Operations
  • Sottofunzione Clinical Trial Support
  • Categoria Experienced Analyst, Clinical Trial Support (P5)
  • Località Breda, North Brabant, Netherlands; Beerse, Antwerp, United States
  • Data di pubblicazione
  • Riferimento 2406173665W
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Descrizione

We are looking for a driven Senior Site Manager (Clinical Research Associate) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in Late Development (phase 1b-2-3). As Senior Site Manager, you will be assigned to trial sites to ensure compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), as well as applicable regulations and guidelines. You will do so from study start-up until site closure. Our new colleague should be flexible and able to work independently. We are seeking to hire a strong communicator and team player, with quick learning and problem-solving abilities. The Senior Site Manager will collaborate with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Clinical Trial Manager (CTM) to ensure overall site management while performing trial-related activities for assigned protocols. 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 executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study-specific systems and other reports/dashboards), and site/study close-out according to SOPs, Work Instructions (WIs), and policies.
  • Responsible for the implementation of an analytical risk-based monitoring model at the site level and to work with the site to ensure timely resolution of issues found during monitoring visits.
  • Participating in site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
  • Attends regularly scheduled team meetings and training.
  • May participate to process improvement and training.
  • May be assigned as a coach or mentor to less experienced colleagues.
  • Leads and/or participates in special initiatives as assigned.
  • May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.

Qualifiche

Education and Experience Requirements:

  • BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
  • A minimum of 3 years of clinical trial monitoring experience 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
  • Fluent in Dutch and English (for candidates based in the Netherlands)
  • Fluent in Dutch, English, and French (for candidates based in Belgium)

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization. We are Janssen!

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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