Johnson & Johnson Careers
Site Manager (Clinical Research Associate)
Requisition ID: 1905769225W
Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical & Diagnostic, Consumer.
Every single day more than 120,000 employees work in 250 companies of the Group, located in 60 countries.
In Italy there are all the three sectors, each of which represents one of the segments mentioned above:
- Janssen SpA (Pharmaceutical Sector): Marketing Company Milan; Plant: Borgo San Michele (Latina)
- Johnson & Johnson SpA (Consumer Sector): Marketing Company and Plant Santa Palomba (Rome)
- Johnson & Johnson Medical SPA (Medical and Diagnostic Sector): Marketing Company Pratica di Mare (Rome).
Janssen-Cilag SpA is looking for a Site Manager/Clinical Research Associate to be hired with a PERMANENT CONTRACT in the Global Clinical Operation Organization.
The Site Manager serves as the primary contact point between the Sponsor and the Investigational Site and 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.
As Site Manager you will mainly:
- Acts as primary local company contact for assigned sites for specific trials.
- Execute site initiation, pre-trial assessment site feasibility and start-up activities
- Prepare and conduct site monitoring (on-site and remote monitoring)
- Site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- BSc or MSc in Scientific field;
- Minimum of 2 years of clinical trial monitoring experience, working as CRA;
- Willingness to travel with occasional overnight stay away from home (max 50%);
- Fluent level of Italian and English;
Will be considered a plus:
- Experience working in the infectious diseases, immunology, psychiatry therapeutic areas
- Experience in pre-trial/evaluation visits and feasibility activities
- Experience in analytical risk-based monitoring
The figure will be located in Cologno Monzese.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen-Cilag S.p.A. (7175)
Clinical Trial Administration