Site Manager

4 weeks ago


Budapest, Hungary Johnson & Johnson Full time
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.

Johnson and Johnson is recruiting for a Site Manager located in Budapest, Hungary.

Contract: Full time

We are looking for a driven Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) in Hungary. 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. Our new colleague should be flexible and is able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real team player. You will collaborate with a Local Trial Manager (LTM), a Clinical Trial Assistant (CTA), and a 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 eager to deliver and helping to improve the lives of millions of patients.

Key Responsibilities:

  • Responsible for activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out in complex clinical trials.
  • 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.
  • Ensure accuracy and completeness of all trial data including safety data. Manage timely data entry and query resolution in collaboration with site staff.
  • Co-create site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
  • Ensures full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trial Managers and central study teams.
  • Be the local expert in clinical trials and build the vital therapeutic area knowledge.
  • May participate to process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.


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