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

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 Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

Job Category:
Professional

All Job Posting Locations:
Milano, Italy

Job Description:

We are looking for a driven Senior Site Manager to serve as the primary contact point between the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4).

As Senior Site Manager, you have to ensure inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure.

Our new colleague should be flexible and is able to work independently.

We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real team player.

You will collaborate with a Local Trial Manager (LTM), a Clinical Trial Assistant (CTA), and a Clinical Trial Manager (CTM) to perform trial-related activities for assigned protocols and sites and you are responsible for the overall site management activities.

You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Principal 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.


* Ensures 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 to process improvement and training.

Leads and/or participates in special initiatives as assigned.

May assume additio...