.Pharmaceutical Research Associates, Inc - SpainNegotiableFull-Time1 positionOverview:ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Responsibilities :What you will be doing :The Associate Director Clinical Trials (ADCT) is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with the heading of a project team, the supervision/control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.Proven success in the oversight and delivery of outsourced clinical trial deliverablesSupport in preparation of regular status reports to SDCO and ADCT / Chief Medical Officer (CMO), including presentation of project status in meetingsOverlooking the clinical operation trial budgetOpportune contact with PM and ADCO in case of divergences from the project planOversight on project timelines and deliverablesSet-up or oversight of study related documents such as Study Management Plan, Monitor Manual, etc.Contribution to and review of study core documents, e.G. synopsis, investigator's brochure, patient informed consent documents etc.Supervision/quality control of the project team member's adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective trainingCo-ordination of project activities with other sponsor departmentsInstruction and supervision of CTCs, CRAs and CTAs (in the scope of a project)Point of contact in case of problems within the clinical trialSupport in planning and conduct of project training prior to starting project activities, oversight if project team has appropriate trainings and report training needs to the ADCOOrganization and conduct of study team meetingsReview of all clinical trial activities from start-up to close outResponsibility for oversight of the Trial Master File (paper or electronic) during the clinical trial and initiation or performance of regular QC checksProcessing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelinesSupport in the process of selection and decision on participation of investigator sitesOrganization and participation in investigator meetingsOversight and handling of contract negotiations with trial sites/pharmacies/local labs in Germany, correspondence with legal