Analista de Pesquisa Clínica Sr (Study Start Up) - GCO Janssen - São Paulo

Job description

In House Sr Site Manager (Analista de Pesquisa Clínica Sr – Study Start Up) – Janssen

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a In House Sr Site Manager (Analista de Pesquisa Clínica Sr – Study Start Up). This position is located in São Paulo / Brazil.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

The In House Sr Site Manager (Analista de Pesquisa Clínica Sr – Study Start Up) will act as a subject matter expert on all SSU-related activities in order to activate trial sites. This role oversees and leads SSU activities in collaboration with other global clinical operations positions and serves as primary contact for investigators and research coordinators in phase I to III clinical trials.

Main responsibilities will include:

· Translation and preparation of Site Informed Consent Form (ICF) in accordance with local IEC and health authority requirements;
· Preparation of documentation for Ethics Committee applications & associated online systems (e.g., Plataforma Brasil);
· Clinical Trial Health Authority application and regulatory submission process, if applicable;
· Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation;
· Review, analysis and collection of metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and site activation;
· Ensure all start up information & requirements are kept up to date in an electronic Trial Master File for project teams;
· Track metrics and study start-up timelines to identify trends and opportunities for improvement.

Desired profile

Qualifications :

Qualifications:
·  A Bachelor's degree in a Health or Science discipline is required.
·  Significant experience in study start up clinical trial is required.
·  Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
·  Experience with Phase II and Phase III Clinical Trials required.
·  Knowledge of the drug development process, including Good Clinical Practices (GCPs), CEP/CONEP & ANVISA Regulations, is required.
·  Experience working with computer software applications is required.
·  Must have strong written and oral communication skills (Portuguese and English).

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.