Lead Site Manager (Senior Clinical Research Associate)
Location: United Kingdom
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 Lead Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 2 to 4. In other organisations, the Lead Site Manager may be known as Senior 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 Haematology Oncology (preference), Solid Oncology or Immunology.
As a Lead 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 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 Trial Delivery 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.
Principal 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 clinical trials. 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. Co-create 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; communicate site and study progress and issues to the Local Trials manager and central study teams. Be the local expert in assigned protocols and build the necessary therapeutic area knowledge. Coach or mentor less experienced colleagues and support the Manager, Clinical Operations in onboarding activities for new hires. Participate in process improvement and training. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or 'Subject Matter Expert'. Support development of site managers and work with the compliance team to implement improvements and training. Qualifications
Education and Experience Requirements:
BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) A minimum of 7 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. 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 organization. We are Janssen!
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. #J-18808-Ljbffr
Location: United Kingdom
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 Lead Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for trials in phases 2 to 4. In other organisations, the Lead Site Manager may be known as Senior 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 Haematology Oncology (preference), Solid Oncology or Immunology.
As a Lead 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 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 Trial Delivery 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.
Principal 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 clinical trials. 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. Co-create 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; communicate site and study progress and issues to the Local Trials manager and central study teams. Be the local expert in assigned protocols and build the necessary therapeutic area knowledge. Coach or mentor less experienced colleagues and support the Manager, Clinical Operations in onboarding activities for new hires. Participate in process improvement and training. Lead and/or participate in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or 'Subject Matter Expert'. Support development of site managers and work with the compliance team to implement improvements and training. Qualifications
Education and Experience Requirements:
BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) A minimum of 7 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. 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 organization. We are Janssen!
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. #J-18808-Ljbffr
