Senior Site Manager (Senior Clinical Research Associate- m / f / x)

Johnson and Johnson; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global healthcare leader in Milan is seeking a professional for R&D Operations. The role involves managing clinical trials, ensuring data accuracy, and collaborating with teams to drive efficiency. Ideal candidates have a BA in Life Sciences and relevant monitoring experience, alongside strong communication skills in English and Italian. The company offers competitive salary, benefits, and flexible working arrangements.

Servizi

Competitive salary

Extensive benefits package

Career development opportunities

Flexible working environment

Competenze

• 3-4 years of clinical trial monitoring experience preferred.
• Understanding of local laws and regulations.
• Proficient in Italian and English.

Mansioni

• Manage site activities in complex clinical trials.
• Ensure accuracy and completeness of trial data.
• Communicate site progress to local and central teams.

Conoscenze

Clinical trial monitoring

GCP understanding

Communication skills

IT skills

Formazione

BA / BS degree in Life Sciences or related field

Descrizione del lavoro

Overview

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Details

Job Function: R&D Operations

Job Sub Function: Clinical Trial Support

Job Category: Professional

All Job Posting Locations: Milano, Italy

Responsibilities

• Responsible for activities ranging from site feasibility and selection over site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site / study close-out in complex clinical trials.
• Responsible for the implementation of a site-level analytical risk-based monitoring model and for working with the site to ensure timely resolution of issues and deviations identified during monitoring visits.
• Ensure accuracy and completeness of all trial data including safety data.
• Manage timely data entry and query resolution in collaboration with site staff.
• Co-create site-level recruitment and retention strategies and implementation of mitigation actions in partnership with other functional areas.
• Ensure full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trial Managers and central study teams.
• Be the local expert in clinical trials and build the necessary therapeutic area knowledge.
• Coach or mentor to less experienced colleagues.
• May participate in process improvement and training.
• Leads and / or participates in special initiatives as assigned.
• May assume additional responsibilities or special initiatives such as "Champion" or "Subject Matter Expert".

Education and Experience Requirements

• BA / BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
• A minimum of 3-4 years of clinical trial monitoring experience is preferred, however, other relevant working experiences and skills may be considered by the hiring manager
• Strong proven understanding of GCP, local laws, and regulations
• Strong IT skills in appropriate software and company systems
• Willingness to travel with occasional overnight stay away from home
• Proficient in Italian and English.

Good written and oral communication skills

Benefits

We offer a competitive salary and extensive benefits package.

The health and well-being of our employees is a priority; we have a flexible working environment as we value work-life balance.

We offer career development opportunities for those who want to grow and be part of our enthusiastic organization.

We are Janssen!

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.