Clinical Research Manager
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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
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