Clinical Research Specialist

Há 5 dias

Paulínia, Brasil Ceva Santé Animale Tempo inteiro

Clinical Research SpecialistThe success of a company depends on the passionate people we partner with.Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked.
More than ever, Ceva is committed to a "One Health" approach.
As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants.
To request an accommodation, please contact a member of the Ceva Talent Acquisition team.Your missions :Plan and conduct clinical studies in animals (pre- and post-registration phases), ensuring compliance with protocols, regulations, and applicable guidelines (MAPA, VICH, GCP).
Develop and review protocols, forms, monitoring plans, and other regulatory and operational documents.Perform on-site and remote monitoring, ensuring protocol adherence, data integrity, and animal welfare.Coordinate study sites and external teams (investigators, CROs, laboratories), ensuring timelines, costs, and quality.Participate in vendor and site selection, qualification visits, and training activities.Conduct critical data analysis and prepare reports and regulatory submission documents.Participate in internal and external audits, contributing to the area's quality system.Support regulatory strategy and the registration of new products in Brazil and Latin America.Contribute to the continuous improvement of clinical research processes and the management of the team's technical-scientific knowledge.Train, guide, and develop junior professionals, promoting technical training and alignment with the company's best practices.Draft, review, and ensure proper implementation of Standard Operating Procedures (SOPs) for the Clinical Research area.Your profile :Bachelor's degree in Veterinary Medicine, Animal Science, or related fields.Solid experience (minimum of 5 years) in veterinary clinical research, preferably in a pharmaceutical company or CRO.In-depth knowledge of GCP, VICH GL9, MAPA regulations, and veterinary product registration processes.Experience in drafting, reviewing, and implementing SOPs, study monitoring, clinical document management, compliance, and good scientific practices.Excellent organizational, communication, and interpersonal skills.Intermediate to advanced English (reading, writing, and speaking).
Intermediate Spanish will be considered a plus.Availability for domestic travel.

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