R&d Clinical Analyst
1 dia atrás
locations- Campinas- time type- Full time- posted on- Posted Today- job requisition id- JR00013405- Role Description
- Responsible for supporting research & development clinical studies for pharmaceutical (antiparasiticides) projects 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 new products licensing 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 start up, investigator training, study conduct, site monitoring and close out. These may include, but are not limited to:
- CRO selection and training.
- To ensure the execution of clinical studies in compliance with good clinical practices, animal welfare and applied legislation
- Preparation of study protocols, data capture forms, electronic data capture, test article documentation and study reports
- Maintaining study files in accordance with Standard Operating Procedures (SOPs) and regulatory requirements
- Assisting in data management processes including data review, tracking and verification
- 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).
- 2. Providesupportfortheelaboration/reviewofqualityassuranceclinical
- 3. Provide support to departmental colleagues
- 4. 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.
- Requirements
- Degree in Veterinary Medicine or other relevant biological field (e.g. biology, animal science, etc);
- Solid experience with veterinary clinical research studies.
- 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 (A strong ability in scientific writing could be an advantage);
- Availability to travel (short periods of 1-5 days) and holds a driver license (category B).
Full time
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