Role Description
Responsible for supporting clinical studies for pharmaceutical and biological products in compliance with appropriate regulatory requirements and internal policies. Effectively collaborates with the cross-functional development team (regional research and development team VMRD- Brazil) to support licensing renewal in Brazil and Latin America.
The position is based in Campinas - São Paulo (hybrid work) with frequent interactions with colleagues and external partners located around Brazil, requiring availability to travel.
Responsibilities
1. Support to all study activities, including planning, study conduct, site monitoring and close out. These may include, but are not limited to:
2. To ensure the execution of clinical studies in compliance with good clinical practices, animal welfare and applied legislation
3. Preparation of study protocols, data capture forms, electronic data capture, test article documentation and study reports
4. Maintaining study files in accordance with Standard Operating Procedures (SOPs) and regulatory requirements
5. Assisting in data management processes including data review, tracking and verification
6. Serve as a communication link between the sponsor and study site, including study site monitoring activities which require ability to travel regularly and independently (short periods of 1-3 days).
7. Providesupportfortheelaboration/reviewofqualityassuranceclinical
8. Provide support to departmental colleagues
9. Collectively responsible for the timely deliverables of new products in Brazil.
He/she will interact with other VMRD colleagues (locally and globally) such as Project Team Leaders, Biometricians, Data Managers and other areas as Regulatory Affairs and Commercial.
Required Experience and Skills:
* Demonstrate good inter-personal communication and presentation skills as this position will interact with other teams and all level of management;
* Good written and oral command of Portuguese and English language
* Availability to travel (short periods of 1-3 days)
Full time