Site Manager (Clinical Research Associate)

at  Johnson Johnson

LOCATION: UK

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/.
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, UK. We are hiring for several therapeutic areas; preferably the candidate will have experience in either Immunology, Ophthalmology, Neuroscience, 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.

EDUCATION AND EXPERIENCE REQUIREMENTS :

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required
• A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
• Knowledge of several therapeutic areas is an asset
• Strong proven understanding of GCP, local laws, and regulations
• Strong IT skills and ability to operate and use various systems and databases
• Ability to establish a home office
• Strong team member and self-starter with the ability to work independently
• Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
• Willingness to travel up to 50% (up to 2-3 days per week) with some overnight stays as necessary

• 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.