Deskripsi
We are looking for a driven Site Manager (Clinical Research Associate) to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 1b, 2 & 3 in Belgium and in The Netherlands. As 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 Clinical Trial Manager (CTM) 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.
Kualifikasi
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
- Proficient in Dutch and English
- Team player
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.