Johnson& Johnson is an American multinational company founded in 1886, a worldleader in the development of products and devices for surgical therapies andpharmaceutical companies, as well as in the marketing of consumer products forpersonal hygiene, and is organized into three business segments:Pharmaceutical, Medical & Diagnostic, Consumer.
Every singleday more than 120,000 employees work in 250 companies of the Group, located in60 countries.
In Italythere are all the three sectors, each of which represents one of the segmentsmentioned 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-CilagSpA is looking for aSenior Local Trial Manager (Senior ClinicalProject Manager),located in Cologno Monzese, to be hired with aPERMANENTCONTRACTin theGlobalClinical OperationOrganization.
A SeniorLocal Trial Manager is responsible for coordinating and leading more complexand startegic clinical studies in the infectious diseases,immunology, psychiatry therapeutic areas .
The SeniorLocal Trial Manager acts as the primary point of contact at a country level forassigned studies and has operational oversight of assigned protocol(s) fromstart-up through to database lock and closeout activities.
As SeniorLocal 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 beconsidered 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 willbe 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 qualifiedapplicants will receive consideration for employment without regard to race,color, religion, sex, sexual orientation, gender identity, age, nationalorigin, or protected veteran status and will not be discriminated against onthe basis of disability.
Janssen-Cilag S.p.A. (7175)