- Managing clinical trials in the country from site selection to post-clinical trial activities, ensuring compliance with ICH/GCP, SOPs, and local regulations.
- Creating, reviewing, and maintaining trial essential documents, and supporting the review of clinical trial dossiers from Ethics Committee and Health Authority.
- Supporting the creation and review of clinical trial budget/payments, as well as contracts with investigational sites/investigators and vendors.
- Planning, conducting, and following up on site visits, including site selection, initiation, monitoring, and close-out.
- Managing local study meetings, local trainings, and ensuring compliance with study timelines and targets, ensuring compliance with study timelines and targets.
- You hold a Bachelor's degree Graduation in health-related areas (e.g. Medicine, Pharmacy, Pharmacy-Biochemistry, Biology, Biomedicine, among others).
- This person is expected to have fluent oral and written English.
- We expect a candidate with at least 4 years in Clinical Research, including 2 years as monitor.
- We' re looking for a candidate who is performance-driven, excels in planning and organization, demonstrates critical thinking and a commitment to continuous improvement, possesses strong relationship and collaboration skills, and exhibits effective leadership capabilities.
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Clinical Research Associate - São Paulo, Brasil - Novo Nordisk
Descrição
At Novo Nordisk we don't wait for change, we drive the change. We're committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. As part of that commitment, we advise you that we will prioritize candidates who self-identify as Black or Pardo throughout the entire selection process for this position.
Are you passionate about clinical research and ensuring compliance with regulations? Do you have experience in managing clinical trials? We are looking for a Clinical Research Associate to join our Clinical Development Center in São Paulo, SP. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.
The Position
As a Clinical Research Associate, your primary responsibilities encompass a range of critical tasks to ensure the successful execution and oversight of clinical trials. A key aspect of your role is to ensure that the quality management system is established, maintained, and continuously improved. This involves developing and implementing standard operating procedures (SOPs), conducting regular audits, and ensuring that all trial activities comply with regulatory requirements and company standards. This position is to work in São Paulo, SP. Your responsabilities includes:
Qualifications
About the Department
The Clinical Development Centre in São Paulo, SP is a dynamic and fast-paced department responsible for running all clinical development activities from initial planning of clinical trials to authority submission. Our team provides resources, processes, and competencies in Biostatistics and Programming, Clinical Reporting, Data Management, Epidemiology/Real World Evidence, and Clinical Pharmacology to all development projects. We are dedicated to conducting clinical evaluation research studies and ensuring the operational aspects of clinical trials are in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
Novo Nordisk is currently the market leader in Diabetes, Obesity and Growth Hormone. We are one of the fastest growing companies in Brazil for 3 years and we expect to continue achieving double-digit growth in the coming years.
Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive change. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 55,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.
Deadline
Apply before June 17th, 2024.
Usuários da profissão Clinical Research Associate em São Paulo
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André Luigi Cleto
Clinical Research Assistant