Johnson and Johnson

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.com

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Breda, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson is currently seeking two Senior Clinical Research Associates (Site Manager) to join our Global Clinical Operations team. One Senior Clinical Research Associates (Site Manager) will be located in Breda, Netherlands and the second one in Beerse, Belgium.

Senior Clinical Research Associate (Site Manager) serves as the primary contact point between the Sponsor and the Investigational Site for trials in Late Development (phase 1b-2-3). 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. You 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'.

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)

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