About UsAs a leading animal health CRO and CDMO, we are partnering with the top global Animal Health Pharmaceutical Companies in the areas of Research and Development (R&D) and manufacturing to produce pharmaceuticals for both farm and companion animals.Originally founded in 2006 by a New Zealand chemist, Argenta's vision is to have healthy animals, making it happen together.Our recipe for success has been our uniqueness in our vision and our people.
Argenta now has operations across New Zealand, the United States, Scotland, Germany, and Spain with more than 600 employees globally.As part of our current expansion, we have an exciting opportunity to be part of Argenta's success and are currently recruiting two Clinical Study Monitors based from our office in San Sebastian (Spain).The Opportunity:As a Clinical Study Monitor, you will be a vital part of our clinical research team, overseeing the clinical studies performed by Argenta and ensuring that they are conducted, recorded, and reported in accordance with the study protocol, Standard Operating Procedures (SOPs), Veterinary Good Clinical Practice (VICH GCP), and the applicable regulatory requirements, ensuring that the success, quality, and integrity of our veterinary clinical studies are upheld.Examples of your responsibilities:Select investigators and sites among veterinary practices.Participate in training activities for investigators and study sites.Conduct study set-up activities (e.G., preparation of study files, equipment).Monitor activities during the study, including:Communication with investigators and laboratories.Monitoring visits / travel to study sites (e.G., veterinary clinics, farms).Track study cases, including enrolment, adverse events (AEs), deviations, and protocol compliance.Monitor laboratory diagnostic activities.Ensure drug accountability by investigators.Perform site close-out visits and related activities.Check, translate, code, and clarify study data in both paper and electronic data capture (EDC) studies.Generate and maintain study documentation and files.Translate key study documentation (subject to language abilities).Participate in the development of study protocol amendments when appropriate.Engage in data management activities (e.G., data entry, user acceptance testing).Communicate occasionally with sponsor representatives for regular reporting.Who we are looking for:We are seeking a talented, skilled, and dynamic individual with a bachelor's degree in veterinary medicine, animal science, life sciences, or a related field (such as biology, agronomy, or pharmacy).A master's degree or specialized training in clinical studies development or monitoring, along with prior experience in a clinical study monitoring environment, is desirable but not essential.Our ideal candidate will have experience with MS Office suites, excellent communication, organizational, and interpersonal skills, and a solid understanding of VICH GCP guidelines and regulatory requirements.Proficiency in Spanish and English is essential.
Fluency in other languages (French, German, etc.)
is desirable, but not essential.You will be committed to continuous learning and professional development.
To support your development, you will attend the office full time for an initial period where you can be supported by your colleagues.If this matches what you are looking for in your next role and your career aspirations, then we would love to hear from you!Please upload your CV and Cover Letter in English for review.#J-18808-Ljbffr