Specialist Site Manager

1 settimana fa

Milano, Italia Johnson & Johnson A tempo pieno

We are looking for a driven Specialist Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4). As Specialist 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 4-5 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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