Senior Clinical Trial Manager
3 settimane fa
Job Summary
Johnson & Johnson is seeking a highly skilled Sr. Site Manager to serve as the primary point of contact between the Sponsor and the Investigational Site for assigned clinical trials in various therapeutic areas. In this role, you will be responsible for ensuring inspection readiness and compliance with clinical trial protocols, Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure.
As a Sr. Site Manager, you will collaborate with a Local Trial Manager, Clinical Trial Assistant, and Clinical Trial Manager to perform trial-related activities and oversee overall site management. You will manage a site-level analytical risk-based monitoring model, work with the site to resolve issues and deviations, and ensure accuracy and completeness of all trial data.
Key Responsibilities
- Responsible for site feasibility and selection, site initiation and start-up, site monitoring, and site / study close-out in complex clinical trials.
- Implement a site-level analytical risk-based monitoring model and work with the site to ensure timely resolution of issues and deviations.
- 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 and communicate site and study progress and issues to the Local Trial Managers and central study teams.
Requirements
- BA/BS degree in Life Sciences, Nursing, or related scientific field (or equivalent experience)
- Minimum of 23 years of clinical trial monitoring experience (preferred)
- Strong understanding of GCP, local laws, and regulations
- Strong IT skills in appropriate software and company systems
- Proficient in Italian and English
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