Site Manager

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; A Senior Site Manager is a mid-level site management role with typically 3-5 years of experience. A Senior Site Manager is 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, site qualification assessment, subject recruitment and retention planning, site initiation on‑site and remote monitoring and close‑out activities. The Senior Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior Site Manager is generally expected to be able to operate independently with little or limited supervision. Acts as primary local company contact for assigned sites for specific trials. # Responsible for executing activities within site initiation and start‑up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specifics 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. Able to implement and execute all tasks independently with little or limited supervision. # Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Ensures site staff complete data entry and resolve queries within expected timelines. # Ensures accuracy, validity and completeness of data collected at trial sites. # Proactively ensures that all adverse events (AE)/serious adverse events (SAE)/product quality complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs ensures that they are consistent with all data collected and with the information in the source documents. # Maintains complete accurate and timely data and essential documents in relevant systems utilized for trial management. # Fully documents trial related activities in particular monitoring. Attends regularly scheduled team meetings and trainings. # Complies with relevant training requirements. Acts as local expert in assigned protocols. 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. compliance monitoring visit (CMV). Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. # On need basis may be assigned as a coach and mentor to a less experienced site manager. # May be required to contribute to process improvement and training. # Reports to a FM / CRM FM / CRM CTA LTM and TDL Other Internal Interfaces : R&D Country Head Therapeutic Area Manager / Physician Compliance Managers / Specialists Training Manager Contracts & Centralized Services (CCS) Local Safety Officer (where required) and Site Manager team. A minimum of 3 years of clinical trial monitoring experience is required. 3-5 years of clinical trial monitoring experience is preferred, however other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility. Strong working knowledge of GCP company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home. Proficient in speaking and writing the country language and English. Business English Clinical Data Management Project Support Training & Development Full‑Time