11 ott - Italia
Trial Form Support
pAs 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 ul licompetitive compensation /li lihealth insurance /li lipension /li licar allowance where applicable /li liManage day-to-day clinical operations for assigned projects per protocol, contracts, and regulatory requirements /li liServe as primary sponsor contact for operational issues and study deliverables /li liLead and coach CRAs, ensuring completion of training requirements /li liOversee site quality and monitoring deliverables through direct supervision /li liDevelop and implement monitoring plans, site training plans, and verification initiatives /li liCoordinate investigator meetings and country/site level reporting /li liEnsure practical,
effective study processes from feasibility to closeout /li liProvide guidance to CRAs on site challenges and escalations /li liSupport recruitment and monitoring strategies to optimize study performance /li liConduct co-monitoring visits and review monitoring reports for timely issue resolution /li liReview CTMS data for accurate country/site/subject informationCollaborate on CRA onboarding, training, and handover with Project Managers /li liContribute to study communications and operational updates /li liOffer insights on resource utilization, revenue recognition, and forecasting /li liParticipate in Investigator Meetings and present monitoring requirements when required /li liPromote proactive issue resolution and a solution-oriented approach /li liSupport business development initiatives, proposals, budget development, and bid defense activities as required /li liMinimum 5 years in clinical research with substantial on-site monitoring experience as a CRA /li liAt least 1 year as an Unmasked CRA/CRM in an Ophthalmology study /li liExperience coordinating or overseeing clinical trial operations at study, country, or regional level /li liStrong understanding of clinical trial processes from startup through closeout /li liIn-depth knowledge of ICH-GCP, regulatory requirements, and clinical research standards /li lileadership /li licommunication /li liproblem-solving /li liICH-GCP /li liregulatory compliance /li limonitoring and quality oversight /li /ul pClinical Research Manager prato, toscana, it /p #J-18808-Ljbffr
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