20 ott - Lazio
Trial Form Support
h3Overview /h3pAs 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.
/ph3Retribuzione / Benefits /h3ullicompetitive compensation /lililunch vouchers /lilihealth insurance /lilipension /lilicar allowance where applicable /li /ulh3Responsabilità /h3ulliManage day-to-day clinical operations for assigned projects per protocol, contracts, and regulatory requirements /liliServe as primary sponsor contact for operational issues and study deliverables /liliLead and coach CRAs, ensuring completion of training requirements /liliOversee site quality and monitoring deliverables through direct supervision /liliDevelop and implement monitoring plans, site training plans, and verification initiatives /liliCoordinate investigator meetings and country/site level reporting /liliEnsure practical,
effective study processes from feasibility to closeout /liliProvide guidance to CRAs on site challenges and escalations /liliSupport recruitment and monitoring strategies to optimize study performance /liliConduct co-monitoring visits and review monitoring reports for timely issue resolution /liliReview CTMS data for accurate country/site/subject information /liliCollaborate on CRA onboarding, training, and handover with Project Managers /liliContribute to study communications and operational updates /liliOffer insights on resource utilization, revenue recognition, and forecasting /liliParticipate in Investigator Meetings and present monitoring requirements when required /liliPromote proactive issue resolution and a solution-oriented approach /liliSupport business development initiatives, proposals, budget development, and bid defense activities as required /li /ulh3Requisiti fondamentali /h3ulliMinimum 5 years in clinical research with substantial on-site monitoring experience as a CRA /liliAt least 1 year as an Unmasked CRA/CRM in an Ophthalmology study /liliExperience coordinating or overseeing clinical trial operations at study, country, or regional level /liliStrong understanding of clinical trial processes from startup through closeout /liliIn-depth knowledge of ICH-GCP, regulatory requirements, and clinical research standards /li /ulullileadership /lilicommunication /liliproblem-solving /liliICH-GCP /liliregulatory compliance /lilimonitoring and quality oversight /li /ul #J-*****-Ljbffr
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