Descrição da Vaga
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of
Companies, is recruiting for a Site Manager (Monitor de Pesquisa Clínica ).
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
The Site Manager (Monitor de Pesquisa Clínica) will be responsible for
site recruitment, patient recruitment and retention planning, site initiation,
monitoring and close-out. Ensure study related activities in compliance with
all Clinical Operations, Standard Operating Procedures (SOPs), policies and
regulatory requirements from Start-Up through Data-Base Lock. Partner with
trial team members to ensure overall site management while performing trial
related activities for assigned protocols. Serve as primary point of contact
and liaison between investigational site staff and study team once site is
initiated. Represent functional area(s) in divisional/company-wide process
Principal responsibilities will include:
- Participate in Site/Investigator feasibility, qualification and selection process by providing recommendations from local area.
- Execute activities within start-up, site monitoring, site management and site/study close-out, according to internal SOPs and policies.
- Write timely Visit Reports and submit via electronic Trial Master File (eTMF).
- Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
- Maintain accurate and timely data in systems utilized for clinical trial management (i.e. CTMS).
- Ensure timely and accurate data collection, documentation and communication of site/study progress and issues.
- Plan, conduct and document site staff training and monitors site performance.
- Present/participate in Investigator Meetings as needed.
- Monitor expiry date of Investigational Product and ensure study supply strategy is adequate.
- Mentor new hires with supervision and serve as Lead SM for a specific trial as needed.
- Review electronic Case Report Forms (eCRFs) and Completion Guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) testing and special initiatives as needed.
- A Bachelor’s degree in a Health or Science discipline is required.
- Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, 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).
- Willingness to travel is required.
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