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Project Manager for EU CRO Pre-clinical Department, based in offices of San Sebastian (Ondax Scientific SLU). Part of Argenta, a leading global Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) focused exclusively on animal health.
Job Responsibility:
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
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)
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
Requirements:
University degree in veterinary medicine, animal science, life sciences, or a related field (such as biology, agronomy, or pharmacy)
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 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
Nice to have:
Master’s degree or specialized training in clinical studies management or monitoring combined with prior experience in a clinical study monitoring environment
additional foreign language skills
What we offer:
Detailed introduction to your field of work
Challenging field of activity contributing to the availability of animal health products
Work in an international team
Family-friendly environment
Options for continuous education
Very positive and collegial team atmosphere in San Sebastian