.You will need to login before you can apply for a job.Site Management Associate (Senior and level I)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.What you will bring:As a Site Management Associate at ICON, you will be responsible for managing, implementing, and monitoring clinical studies, with support, in a team setting within a global organization. Following an initial training period, you will begin working on large global projects within a variety of therapeutic areas. The work of a Site Management Associate is varied and challenging whilst offering you the opportunity to use your language skills. Your responsibilities will include:Complete essential document collection and review throughout the study lifecycle inclusive site activation.Manage the electronic Trial Master File for each site, performing periodic QCs and site level maintenance of the eTMF.Update Clinical Management Systems, local regulatory tasks, protocol amendments, submissions packages preparations for sites/ethics committees submissions.Conduct remote site monitoring visits and/or targeted on-site visits as needed.Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks.Perform study tracking CTMS.Act as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies, and conducting offsite central monitoring visits and contacts (pre-study, initiation, monitoring, and close out visits). Escalate issues and risks as needed.Provide training and mentoring to less experienced team members.Act or assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management and evaluation of metrics to identify process improvements.Contribute to business development activities by participating in proposals and bid defenses.Support manager and interface with partner departments to support enhanced project delivery. May create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.Your profile:Bachelor's Degree, preferable in health/sciences.In-depth knowledge of the drug development process.+3 years experience in a similar position.Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure, and ICFs.In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.Advanced English level (oral and written) - mandatory.Monitoring/remote monitoring experience (recommended for level I - mandatory for senior)