Senior Site Manager - Oncology, Southeast US (1 of 3)

Johnson & Johnson is seeking a Senior Site Manager – Oncology to serve as the primary contact between the Sponsor and the Investigational Site across the southeastern United States. Purpose The Senior Site Manager (Senior SM) will ensure site readiness and compliance with clinical trial protocols, SOPs, GCP, and relevant regulations from study start‑up through site closure. The role supports site selection, qualification, recruitment, initiation, monitoring, and close‑out, and collaborates with the Local Trial Manager and other study team members. Key Responsibilities Serve as the primary local company contact for assigned sites. Participate in site feasibility and Site Qualification Visits (SQVs) and investigator meetings. Execute site initiation, start‑up, monitoring (including remote monitoring), and close‑out activities in accordance with SOPs, WIs, and policies. Implement analytical risk‑based monitoring and resolve site issues promptly. Ensure site staff are trained and that training records are complete and accurate. Coordinate recruitment strategy, contingency planning, and supply management. Maintain accurate data entry and resolution of queries within expected timelines. Report AEs/SAEs/PQCs within required timelines and maintain audit trail. Document trial activities, write visit reports, and communicate status to stakeholders. Support CAPA completion for QA audits and quality issues. Assist with Health Authority (HA), Independent Ethics Committee (IEC)/IRB submissions as needed. Mentor and coach less experienced site managers. Participate in special initiatives and occasional leadership roles. Qualifications / Requirements Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related scientific discipline. Minimum 2 years of clinical trial monitoring experience. Minimum 2 years of oncology clinical trial experience. Experience with Phase II and Phase III trials preferred. Knowledge of GCP, FDA regulations, company SOPs, and local laws. Strong computer skills with relevant clinical systems. Excellent written and oral communication skills. Willingness to travel up to 60% with overnight stays. Valid driver’s license and good driving record. Required Skills Business Behavior Clinical Data Management Clinical Trials Operations Execution Focus Laboratory Operations Mentorship Proactive Behavior Problem Solving Process Improvements Project Support Regulatory Environment Regulatory Inspections Research and Development Research Ethics Study Management Time Management Preferred Skills Business English Clinical Data Management Clinical Trials Operations Execution Focus Laboratory Operations Mentorship Proactive Behavior Problem Solving Process Improvements Project Support Regulatory Environment Regulatory Inspections Research and Development Research Ethics Study Management Time Management EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities under VEVRAA and Section 503 of the Rehabilitation Act. Job Posting Closure The job posting is anticipated to close on June 5th, 2026. #J-18808-Ljbffr