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    Site Manager - High Wycombe, United Kingdom - Johnson & Johnson

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    Full time
    Description

    Site Manager

    We are looking for a driven Site Manager to serve as the primary contact point between Janssen Research & Development and the Investigational Site for trials in phases 2-4. In other organisations, the Site Manager may be known as Clinical Research Associate or Monitor. The head office location is in High Wycombe, Buckinghamshire, and this position is home-based. We are hiring for several therapeutic areas; preferably the candidate will have experience in either Immunology, Ophthalmology, Haematology or Oncology.

    As a 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 as well as part of a team, 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. You are responsible for the overall site management activities. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients. You will also be part of a wider local UK team that provides mutual support and opportunities to work together to identify new and improved ways of working.

    Principal Responsibilities:

    • Responsible for activities ranging from site feasibility and selection, site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and 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.
    • Ensure accuracy and completeness of all trial data including safety data. Manage timely data entry and query resolution in collaboration with site staff.
    • Contribute to site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
    • Ensure full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trial Manager and central study teams.
    • Be the local expert on your assigned protocols and build the necessary therapeutic area expertise.
    • Opportunity to be a participant in process improvement and training.


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