Job Description - Senior Site Manager, Early Development (Senior Clinical Research Associate/ Senior CRA) (2506230399W)
Senior Site Manager, Early Development (Senior Clinical Research Associate/ Senior CRA)
We are looking for a Senior Site Manager, Early Development (ED) 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 Sr. 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 some 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. 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 early phase clinical trials in compliance with SOPs, GCP, and applicable regulations. Act as the primary site contact, addressing issues, resolving deviations, and ensuring timely progress and data accuracy. Implement risk-based monitoring strategies and collaborate on recruitment, retention, and contingency plans. Ensure site staff are adequately trained, study supplies are managed, and investigational products are handled appropriately. Oversee timely data entry, query resolution, and accurate documentation of trial-related activities. Report and document adverse events, maintain essential files, and ensure inspection readiness at all times. Partner with internal and external stakeholders to drive site-level performance, ensure quality, and complete corrective actions for audit findings. Mentor less experienced colleagues, contribute to process improvements, and support special initiatives as assigned. Education and Experience 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. 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 organization. Equal Opportunity Employer:
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.
#J-18808-Ljbffr
We are looking for a Senior Site Manager, Early Development (ED) 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 Sr. 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 some 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. 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 early phase clinical trials in compliance with SOPs, GCP, and applicable regulations. Act as the primary site contact, addressing issues, resolving deviations, and ensuring timely progress and data accuracy. Implement risk-based monitoring strategies and collaborate on recruitment, retention, and contingency plans. Ensure site staff are adequately trained, study supplies are managed, and investigational products are handled appropriately. Oversee timely data entry, query resolution, and accurate documentation of trial-related activities. Report and document adverse events, maintain essential files, and ensure inspection readiness at all times. Partner with internal and external stakeholders to drive site-level performance, ensure quality, and complete corrective actions for audit findings. Mentor less experienced colleagues, contribute to process improvements, and support special initiatives as assigned. Education and Experience 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. 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 organization. Equal Opportunity Employer:
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.
#J-18808-Ljbffr
