14 ott - Italia
Altro
h3Overview /h3 /brpbr/Se i requisiti e l'esperienza richiesti per questo lavoro corrispondono alle sue competenze, la preghiamo di candidarsi tempestivamente.br/ /p /brpAs Clinical Research Manager (CRM) in Ophthalmology, you lead clinical operations across multiple studies and countries. You will ensure compliance with ICH-GCP, SOPs, and contracts while partnering with PMs, CRAs, sponsors, and sites. This role focuses on delivering trials on time, in scope, and to high quality, within a global CRO environment. Your work helps advance innovative ophthalmic therapies and improve patient outcomes. The position offers home-based work in Poland, Spain, or Italy and exposure to cross-functional, internationally distributed teams. /p /brh3Retribuzione / Benefits /h3 /brul /brlicompetitive compensation /li /brlilunch vouchers /li /brlihealth insurance /li /brlipension /li /brlicar allowance where applicable /li /br /ul /brh3Responsabilità /h3 /brul /brliManage day-to-day clinical operations for assigned projects per protocol, contracts, and regulatory requirements /li /brliServe as primary sponsor contact for operational issues and study deliverables /li /brliLead and coach CRAs, ensuring completion of training requirements /li /brliOversee site quality and monitoring deliverables through direct supervision /li /brliDevelop and implement monitoring plans, site training plans, and verification initiatives /li /brliCoordinate investigator meetings and country/site level reporting /li /brliEnsure practical,
effective study processes from feasibility to closeout /li /brliProvide guidance to CRAs on site challenges and escalations /li /brliSupport recruitment and monitoring strategies to optimize study performance /li /brliConduct co-monitoring visits and review monitoring reports for timely issue resolution /li /brliReview CTMS data for accurate country/site/subject information /li /brliCollaborate on CRA onboarding, training, and handover with Project Managers /li /brliContribute to study communications and operational updates /li /brliOffer insights on resource utilization, revenue recognition, and forecasting /li /brliParticipate in Investigator Meetings and present monitoring requirements when required /li /brliPromote proactive issue resolution and a solution-oriented approach /li /brliSupport business development initiatives, proposals, xlwpduy budget development, and bid defense activities as required /li /br /ul /brh3Requisiti fondamentali /h3 /brul /brliMinimum 5 years in clinical research with substantial on-site monitoring experience as a CRA /li /brliAt least 1 year as an Unmasked CRA/CRM in an Ophthalmology study /li /brliExperience coordinating or overseeing clinical trial operations at study, country, or regional level /li /brliStrong understanding of clinical trial processes from startup through closeout /li /brliIn-depth knowledge of ICH-GCP, regulatory requirements, and clinical research standards /li /brlileadership /li /brlicommunication /li /brliproblem-solving /li /brliICH-GCP /li /brliregulatory compliance /li /brlimonitoring and quality oversight /li /br /ul #J-18808-Ljbffr
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