Johnson & Johnson Careers
Site Manager/Clinical Research Associate – Start-up
Requisition ID: 1905754683W
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 – Start-Up to be hired with a PERMANENT CONTRACT in the Global Clinical Operation Organization.
The start-up is a very exciting but challenging period in the life-cycle of a clinical trial. Getting sites quickly and efficiently to the point where they can enroll subjects is crucial to the overall timelines of a study.
As a Start-up Site Manager, you will mainly work on newly projects. In particular, you will:
- Be the initial contact with the site and you will conduct feasibility activities on a country level.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas, as needed.
- Evaluate the site and bring it to the point where it is formally selected - or rejected.
- 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 across different therapeutic areas.
- 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 activation.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
Your assessment will play a key role in the selection of appropriately qualified sites, thus contributing to the achievement of project operational goals and impacting on the success of the projects.
- BSc or MSc in Scientific field
- Minimum of 2 years of experience, working as CRA, in pre-trial/evaluation visits and feasibility activities
- Willingness to travel with occasional overnight stay away from home (max 50%).
- Fluent level of Italian and English.
- Experience working in different therapeutic areas will be a plus.
The figure will be located in Cologno Monzese.
Janssen-Cilag S.p.A. (7175)
Clinical Trial Administration