Associate Site Manager

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

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Associate Site Manager

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

We are searching for the best talent for a driven Associate Site Manager to serve as the primary contact point between J&J Innovative Medicine 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, UK and this position is home-based. The position is within the Immunology therapeutic area and will include monitoring a variety of trials in different indications.

As an Associate 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 Local Trial Managers (LTMs), Clinical Trial Assistants (CTAs), and a Trial Delivery Manager (TDM) 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.

Are you ready to join our team? Then please read further!

You will be 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.
• 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.
• Ensuring accuracy and completeness of all trial data including safety data. Managing timely data entry and query resolution in collaboration with site staff.
• Contributing to site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
• Ensuring full documentation of trial related activities in all study files; communicating site and study progress and issues to the Local Trial Managers and central study teams.
• Being the local expert on your assigned protocols and building the necessary therapeutic area expertise.
• Opportunity to be a participant in process improvement and training.

Qualifications/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 2 years 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
• Proficient in English. Good written and oral communication skills.

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 organisation.

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.