Clinical Research Associate

3 settimane fa

Cologno Monzese, Italia Johnson & Johnson A tempo pieno

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 driven **Site Manager / Clinical Research Manager** to serve as the primary contact point the Sponsor and the Investigational Site for assigned clinical trials (phase 1-4) within the assigned Therapeutic Area that will be decided based on workload distribution.
As Site Manager / Clinical Research 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. We need a flexible Site Manager who is able to work independently, is a real teammate, a quick learner, a problem solver, and a good communicator. 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, through site initiation and start-up, to preparation and conduct of site monitoring, oversight of key performance indicators and site/study close-out.
- 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.
- Contributing to 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 Trials manager and central study teams.
- Be the local expert in assigned protocols and build the necessary therapeutic area knowledge.
- May participate to process improvement and training.
**The role is 100% remotely and field-based.**
**Qualifications**:
EDUCATION AND EXPERIENCE REQUIREMENTS:
- BSc/BA degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
- Previous clinical trial monitoring experience (1year) is preferred, however, other relevant working experiences and skills will 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 local language(s) and English. Good written and oral communication skills
- 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"_

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