
Chief Research Clinical Operations Manager
Há 2 dias
This role is part of our cross-functional development team responsible for supporting research & development clinical studies for pharmaceutical projects in compliance with regulatory requirements and internal policies. The position involves collaborating with the regional research and development team to support new products licensing in Brazil and Latin America.
The Senior Research Clinical Coordinator will be based in Campinas - São Paulo (hybrid work) with frequent interactions with colleagues and external partners located around Brazil, requiring availability to travel. The position requires excellent communication skills to effectively collaborate with the team and interact with other departments such as Project Team Leaders, Biometricians, Data Managers and Regulatory Affairs.
The ideal candidate will have a degree in Veterinary Medicine or a relevant biological field, solid experience with veterinary clinical research studies, good written and oral command of Portuguese and English language, and the ability to travel (short periods of 1-5 days).
Responsibilities:- Support all study activities including start up, investigator training, study conduct, site monitoring and close out.
- Collaborate with the cross-functional development team to ensure the execution of clinical studies in compliance with good clinical practices and regulatory requirements.
- Prepare study protocols, data capture forms, electronic data capture, test article documentation and study reports.
- Maintain study files in accordance with Standard Operating Procedures (SOPs) and regulatory requirements.
- Assist in data management processes including data review, tracking and verification.
- Graduate degree in Veterinary Medicine or a relevant biological field.
- Solid experience with veterinary clinical research studies.
- Excellent communication and presentation skills.
- Good written and oral command of Portuguese and English language.
- Ability to travel (short periods of 1-5 days).
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