Clinical Study Manager Senior - UV-688Pubblicato il 01-02-2021 - Johnson & Johnson in Cologno Monzese
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 Senior Local Trial Manager (Senior Clinical Project Manager), located in Cologno Monzese, to be hired with a PERMANENT CONTRACT in the Global Clinical Operation Organization .
A Senior Local Trial Manager is responsible for coordinating and leading more complex and startegic clinical studies in the infectious diseases, immunology, psychiatry therapeutic areas .
The Senior Local Trial Manager acts as the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
As Senior Local Trial Manager you will mainly:
- Collaborate with Clinical Research Manager for country protocol feasibility and site feasibility assessment
- Collaborate with other Study Team Members to select final site list
- Leads and coordinates local trial team activities in compliance with SOPs
- Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget
- Participate in the optimization of local processes and mentoring activities for junior LTMs.
- Ensures that all Adverse Events/Product Quality Complaints are reported within the required reporting timelines; prepares country specific informed consent in accordance with procedural document/templates; maintains and updates trial management systems
- Assists in negotiation of trial site contracts and budgets; forecasts and manages country/local trial budget to ensure accurate finance reporting
- Acts as subject matter expert for assigned protocols; develops strong therapeutic knowledge to support roles and responsibilities; actively leads or contributes to process improvement, training and mentoring of CTAs, Monitors and other LTMs.
- Acts as primary local/country contact for a trial; establishes and maintains excellent working relationships with external (investigators, study trial coordinators and other site staff) and internal stakeholders (Medical Affairs and Marketing for Medical Affairs trials)
- BSc or MSc in Scientific field;
- At least 4 years of experience as Study Manager in clinical trials, plus 4 years of previous experience as CRA;
- Willingness to travel occasionally (max 20% travel percentage – national or international);
- Fluent level of Italian and English;
- Strong Project Management skills and experience working in matrix organization;
Will be considered a plus:
- Experience working in the infectious diseases, immunology, psychiatry therapeutic areas.
- Experience in management of mixed remote teams (Flex and FTE)
- Experience working in a pharmaceutical company.
The person will be located on site in Cologno Monzese with 1 day of smart working per week.
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.