Site Manager/Clinical Research Associate Cologno Monzese

Site Manager/Clinical Research Associate
Cologno Monzese
Lombardia, Cologno Monzese

At Janssen, we're creating a future where disease is a thing of the past.

We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We have 40, 000 people around the world who show up every day to achieve the unimaginable.

This work requires heart, science, and ingenuity.

We never stop imagining a future where the most challenging diseases are a thing of the past.

We are 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 is 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.

**Qualifications

Requirements

- BSc or MSc in Scientific field

- Minimum of 1 year of clinical trial monitoring experience, working as CRA

- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and

- associated protocol specific procedures including monitoring guidelines

- 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 Oncology, Onco-hematology, Immunology and/or Neuroscience area

- Experience in analytical risk-based monitoring

The person will be located in Cologno Monzese

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Italy are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.

No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!

**Primary Location

Italy-Lombardia-Cologno Monzese

- **Organization

Janssen-Cilag S. p. A. (7175)

**Job Function

R&D

**Requisition ID

2206019509W