About this roleTFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.The Senior Clinical Research Associate is responsible for monitoring and managing sites based in Portugal.Please, keep in mind that this is a Freelance role for only 0.2 FTE.As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.Key ResponsibilitiesIndependently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the applicable monitoring planOversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issuesReview e CRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsorsReview and maintain study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulationsCollaborate cross-functionally with medical, project management, quality management, and data management teams, and support sites during audits and inspectionsQualificationsDegree in a scientific or medical discipline, or completed vocational training in a relevant healthcare or medical fieldAdditional training in clinical research or CRA certification, combined with several years of experience as a Clinical Research AssociateStrong knowledge of GCP, ICH guidelines, and clinical research processes, with a high level of accuracy in handling study data and regulatory requirementsFluent Portugese and English language skills, both written and spoken, with willingness to travel nationally and internationally as requiredMust Have: Extensive experience in Medical Device studies and ISO14155 knowledge.What We OfferWe provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.