Descrição da Vaga
Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of
Companies, is recruiting for a Senior Local Trial Manager. 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
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate
with the world for the health of everyone in it.
The Local Trial Manager (Coordenador de Pesquisa Clínica) will have
responsibilities that include trial operations/oversight at the country level
by ensuring study related activities are in compliance with all Standard
Operating Procedures (SOPs), policies and regulatory requirements from Start-
Up through Data-Base lock.
Principal responsibilities will include:
- Supervise site/investigator selection process and monitor site performance for assigned country.
- Partner with the clinical/internal colleagues to ensure successful execution of clinical trials, while performing trial related activities for assigned protocols.
- Participate in divisional/company-wide process initiatives.
- Support country/site feasibility assessment in conjunction with clinical/internal colleagues.
- Collaborate with the clinical colleagues to select final site list and hold weekly meetings and provide team members training when needed (i.e. for implementation of study amendments/changes in study processes).
- Contribute to the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates for a single country trial.
- Create various trial related documents such as the Country Feasibility Report and country specific ICF template.
- Submit requests for vendor services and support vendor selection.
- Plan and review study budget with relevant team members and update budget forecast.
- Process, review and approve site and local vendor invoices.
- Review electronic Case Report Forms (eCRFs) and Completion guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) in conjunction with clinical/internal colleagues.
- Collaborate with Clinical Data Manager (CDM) during analyses to ensure report accuracy and to resolve site specific data issues.
- Contribute to recruitment strategy and contingency plan in partnership with other Trial Team members.
- Coordinate/present at Investigator Meetings as needed and attend regularly scheduled team meetings and trainings.
- Track, review and sign-off on Site Manager Trip Reports. Identify trends across the project and escalate as appropriate.
- Support regulatory requests as appropriate. Maintain/update all relevant systems (i.e. electronic Trial Master File (eTMF), and Clinical Trial Management System) and ensure all activities are executed according to internal SOPs and policies.
- A Bachelor's degree in a Health or Science discipline is required.
- Clinical project management experience is preferred.
- Prior experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Previous clinical operations experience is required.
- Knowledge of the drug development process, including Good Clinical Practices (GCPs), CEP/CONEP & ANVISA Regulations, is required.
- Experience working with computer software applications required.
- Must have strong written and oral communication skills (Portuguese and English).
- Business travel (meetings, training, etc.) may be 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