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Johnson & Johnson > offerta di lavoro n. 230023

immagine: lavoro con Johnson & Johnson

Senior Site Manager (Senior Clinical Research Associate)

> 1905768049W

contratto
Assunzione alle dipendenze

durata
Tempo indeterminato

regime orario
Full time

luogo di lavoro
IT Lombardia, Cologno Monzese (MI)

area professionale
Direzione, Legale, Project Management

livello professionale
Senior

offerta non piu attiva

Descrizione della posizione

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 2 Senior Site Managers (Sr.Clinical Research Associate) to be hired with a PERMANENT CONTRACT in the Global Clinical Operation Organization.

A Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. A Senior Site Manager 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. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Site Manager will 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. A Senior Site Manager may contribute to process improvement, training and mentoring of other Site Managers.

 

As Sr. 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. 



Qualifications

  • BSc or MSc in Scientific field;
  • Minimum of 4 years of clinical trial monitoring experience, working as CRA;
  • Willingness to travel with occasional overnight stay away from home (max 50% Travel percentage – national or international);
  • Fluent level of Italian and English;
  • Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems.

Will be considered a plus:

  • Experience working in the Onco-hematology and/or Pulmonary Hypertension area.
  • 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.



Primary Location
Italy-Lombardia-Cologno Monzese
Organization
Janssen-Cilag S.p.A. (7175)
Job Function
Clinical Trial Administration

Avvertenze

La presente inserzione è pubblicata allo scopo esclusivo di raccogliere candidature in relazione ad opportunità di lavoro o formazione effettivamente esistenti presso la nostra azienda o presso società controllate o partecipate. È pertanto esclusa qualsiasi finalità di intermediazione. La ricerca è rivolta a candidati di entrambi i sessi (L.903/77). I dati saranno trattati ai sensi del Regolamento UE 2016/679.

offerta non piu attiva