Job Description

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 Project Management

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

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Senior Site Manager, Early Development (Senior Clinical Research Associate/ Senior CRA)

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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

Senior Site Manager, Early Development (ED), located United Kingdom

to serve as the primary contact point between the Sponsor and the Investigational Site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology (ED&CP) studies. A Senior Site Manager Early Development is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations, and guidelines from start-up through data-base lock. Responsibilities include site assessments, pretrial assessments, site selection, site initiation, subject recruitment and retention, monitoring, and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM), Site Strategy Lead (SSL) and Trial Delivery Leader (TDL) to ensure overall site management while performing trial related activities for assigned protocols.


The head office location is in High Wycombe, Buckinghamshire and this position is field-based with regular in-office requirement. Preferably you will have experience in Haematology or Oncology but other therapeutic areas are considered.


As a Senior Site Manager, you will be responsible for maintaining ongoing 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. You should be flexible and be able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real teammate. You will be responsible for oversight of clinical trial protocols at a site level and will collaborate closely with a Local Trial Manager (country project manager), Clinical Trial Assistant, and Clinical Trial Manager (regional project manager).


You will work in a hardworking, enthusiastic, and committed study team eager to deliver and help 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.

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You will be 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 early phase clinical trials in compliance with SOPs, GCP, and applicable regulations. Acting as the primary site contact, addressing issues, resolving deviations, and ensuring timely progress and data accuracy. Implementing risk-based monitoring strategies and collaborate on recruitment, retention, and contingency plans. Ensuring site staff are adequately trained, study supplies are managed, and investigational products are handled appropriately. Overseeing timely data entry, query resolution, and accurate documentation of trial-related activities. Reporting and documenting adverse events, maintain essential files, and ensure inspection readiness at all times. Partnering with internal and external stakeholders to drive site-level performance, ensure quality, and complete corrective actions for audit findings. Mentoring less experienced colleagues, contribute to process improvements, and support special initiatives as assigned. May participate to process improvement and training. Leading 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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Qualifications / 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. Knowledge of several therapeutic areas is an asset; oncology or haematology is preferred. 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% maximum (up to 2-3 days per week) with some overnight stays as necessary Preferred therapeutic experience: Haematology or Oncology
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While we have a preferred candidate for this position, we welcome applications from all qualified individuals.

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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 important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.