Sr. Site Manager
1 settimana fa
We are looking for a driven Senior Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) within the assigned Therapeutic Area that will be decided based on workload distribution. As Senior Site Manager, you have to ensure 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. Our new colleague should be flexible and is able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real team player. You will collaborate with a Local Trial Manager (LTM), a Clinical Trial Assistant (CTA), and a Clinical Trial Manager (CTM) to perform trial-related activities for assigned protocols and sites and you are responsible for the overall site management activities. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.
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 progress and issues to the Local Trial Managers and central study teams.
- Be the local expert in clinical trials and build the necessary therapeutic area knowledge.
- Coach or mentor to less experienced colleagues.
- May participate to process improvement and training. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.
**Qualifications**:
EDUCATION AND EXPERIENCE REQUIREMENTS:
- BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
- A minimum of 2-3 years of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
- Strong proven understanding of GCP, local laws, and regulations
- Strong IT skills in appropriate software and company systems
- Willingness to travel with occasional overnight stay away from home
- Proficient in Italian and English. Good written and oral communication skills
BENEFITS:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our enthusiastic organization. We are Janssen
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
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