Descripción de la oferta
Companies in the animal health and animal feed sectors require qualified support for the development and regulatory approval of their products. Argenta is a leading, specialized global Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) focused exclusively on animal health.
As part of our continued growth, we are pleased to offer an exciting opportunity to contribute to Argenta’s success and are currently recruiting a Project Manager for our EU CRO Pre-clinical Department, based in our offices of San Sebastian (Ondax Scientific SLU).
Ondax Scientific SLU, part of Argenta, is an internationally recognised provider of expert services in the veterinary medicine and animal feed sector
To support our team, we are currently seeking a:
Project Manager Pre-Clinical Studies (m/f/x) – Full-time
Your tasks:
Complying with the responsibilities as defined by VICH GCP (Veterinary Good Clinical Practice), GLP (Good Laboratory Practice), and all applicable regulatory requirements
Advising clients on study design and placement of GCP/GLP field and laboratory studies in Europe and internationally
Building, coordinating and leading multidisciplinary teams across individual studies, including selection and training of investigators, study set-up activities, among others
Monitor activities during the study, including communication with investigators and laboratories, on site visits/travel to study sites (e.g., veterinary clinics, farms), tracking of study cases (including enrolment, adverse events (AEs), deviations, and protocol compliance), supervision of laboratory diagnostic activities, drug accountability, tracking of financial aspects of study sites (checking and approving invoices), among others.
Continuous quality control of the study data collected within the scope of the study and their evaluation in the context of GCP/GLP quality standards
Preparation/review of study protocols and final study reports in the context of GCP/GLP quality standards
Managing project budgets and reporting to middle management.
Your profile:
Talented, skilled, and dynamic individual with an University 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 management or monitoring, combined with prior experience in a clinical study monitoring environment, is considered an asset
Able to be to familiarize yourself with new tasks and areas of knowledge
Independent and structured way of working
Reliability and high sense of responsibility
Excellent command of written and spoken English; additional foreign language skills are considered an asset
Good teamwork and communication skills
Willingness to travel for business (approx. 30% of working time)
Driver’s license class B
We offer you a detailed introduction to your field of work, a challenging field of activity contributing to the availability of animal health products, to work in an international team, a family-friendly environment, options for continuous education and a very positive and collegial team atmosphere in San Sebastian.
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