Description

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.

Janssen-Cilag SpA is looking for a Senior Site Manager – Start-Up,  to be hired with a  PERMANENT CONTRACT  in the Global Clinical Operation Organization .

 

The start-up is a very exciting but challenging period in the life-cycle of a clinical trial. Getting sites quickly and efficiently to the point where they can enroll subjects is crucial to the overall timelines of a study.

As a Start-up Senior SM, you will mainly work on newly projects. You are the initial contact with the site and you will conduct feasibility activities on a country level.
You will evaluate the site and bring it to the point where it is formally selected - or rejected. Your assessment will play a key role in the selection of appropriately qualified sites, thus contributing to the achievement of project operational goals and impacting on the success of the projects.

Senior Site Manager-SU will partner with the Local Trial Manager (LTM), Local Trial Manager Start Up, Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols across different therapeutic areas.

He/She will also 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 activation.

Main responsibilities:

-       Acts as primary local company contact for assigned sites for specific trials during the SU phase.

-       Participate in protocol/Country/site feasibility and/or pre-trial site assessment visits

-       Conduct pre-trial assessment visits at key sites across the different therapeutic areas

-       Responsible for executing activities within site initiation and start-up, as needed

-       Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas, as needed.

-       Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct, as needed.

-       Collect and maintains complete and accurate essential documents, as needed

-       Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.

-       May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.

  The role is 100% remotely and field-based.

Qualifications

Requirements:

-       A minimum of BA or BS degree in Life Sciences, Nursing or related scientific field

-       Minimum of two - three years of clinical trial monitoring experience 

-       Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

-       Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.

Proficient in speaking and writing the country language and English. Good written and oral communication

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”!