Clinical Research Manager

2 giorni fa

Campagna, Campania, Italia Trial Form Support Tempo pieno

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.
/pullicompetitive compensation /lilihealth insurance /lilipension /lilicar allowance where applicable /liliManage 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 /liliMinimum 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 /lilileadership /lilicommunication /liliproblem-solving /liliICH-GCP /liliregulatory compliance /lilimonitoring and quality oversight /li /ulpClinical Research Manager
• salerno, campania, it /p #J-*-Ljbffr