10 ott - Bardi
Altro
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
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