Clinical Research Manager

7 ore fa

Bergamo, Lombardia, Italia Trial Form Support Tempo pieno

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Overview As 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. Retribuzione / Benefits
* competitive compensation
* lunch vouchers
* health insurance
* pension
* car allowance where applicable Responsabilità
* Manage day-to-day clinical operations for assigned projects per protocol, contracts, and regulatory requirements
* Serve as primary sponsor contact for operational issues and study deliverables
* Lead and coach CRAs, ensuring completion of training requirements
* Oversee site quality and monitoring deliverables through direct supervision
* Develop and implement monitoring plans, site training plans, and verification initiatives
* Coordinate investigator meetings and country/site level reporting
* Ensure practical, effective study processes from feasibility to closeout
* Provide guidance to CRAs on site challenges and escalations
* Support recruitment and monitoring strategies to optimize study performance
* Conduct co-monitoring visits and review monitoring reports for timely issue resolution
* Review CTMS data for accurate country/site/subject information
* Collaborate on CRA onboarding, training, and handover with Project Managers
* Contribute to study communications and operational updates
* Offer insights on resource utilization, revenue recognition, and forecasting
* Participate in Investigator Meetings and present monitoring requirements when required
* Promote proactive issue resolution and a solution-oriented approach
* Support business development initiatives, proposals, budget development, and bid defense activities as required Requisiti fondamentali
* Minimum 5 years in clinical research with substantial on-site monitoring experience as a CRA
* At least 1 year as an Unmasked CRA/CRM in an Ophthalmology study
* Experience coordinating or overseeing clinical trial operations at study, country, or regional level
* Strong understanding of clinical trial processes from startup through closeout
* In-depth knowledge of ICH-GCP, regulatory requirements, and clinical research standards
* leadership
* communication
* problem-solving
* ICH-GCP
* regulatory compliance
* monitoring and quality oversight

Clinical Research Manager

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