Senior Site Manager

JOHNSON & JOHNSON ,
High Wycombe, Buckinghamshire
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Job Description

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.At Janssen, we discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information.We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.Position Summary: Serving as the primary contact point between the Sponsor and the Investigational Site, you will be assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. You could contribute to process improvement, training and mentoring of other Site Managers.Principal Responsibilities: * Acting as primary local company contact for assigned sites for specific trials. * Participating in site feasibility and/or pre-trial site assessment visits * Attending and participating in investigator meetings as needed. * Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. * Ensuring site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in the shortest possible timeframe. * Contributing to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. * Ensuring site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. * Ensuring that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. * Ensures site staff complete data entry and resolve queries within expected timelines. * Ensuring accuracy, validity and completeness of data collected at trial sites * Ensuring that all Adverse Events (AE) /Serious Adverse Events (SAEs )/ Product Quality Complaints (PQCs) are reported and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. * Maintaining complete, accurate and timely data and essential documents in relevant systems utilized for trial management. * Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate partners. * Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. * Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team. * Attends regularly scheduled team meetings and trainings. * Aligns with relevant training requirements. Act as local specialist in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. * Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV). * Prepares trial sites for close out, conduct final close out visit. * Tracks costs at site level and ensure payments are made, if applicable. * Establishes and maintains good working relationships with internal and external partners in particular investigators, trial coordinators and other site staff. * Acts as a point of contact in site management practices and may b

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