Lead Site Manager

Lead Site Manager
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 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.

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 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 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.


* Ensures full documentation of trial related activities in all study files; communicates site and study progr...