Clinical Research Manager
Pubblicato il 06-10-2026 - Altro in Bologna
Overview
Se i requisiti e l'esperienza richiesti per questo lavoro corrispondono alle sue competenze, la preghiamo di candidarsi tempestivamente.
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, xlwpduy 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