Clinical Research Manager

Trial Form Support; Prato; Remote; EUR 90,000 - 120,000; Full time

Job summary

Trial Form Support seeks a Clinical Research Manager (CRM) in Ophthalmology to lead clinical operations across multiple studies and countries within a global CRO setting.

You will ensure ICH-GCP and contracts compliance while partnering with PMs, CRAs, sponsors, and sites, delivering trials on time, in scope, and to high quality. This home-based role spans Poland, Spain, and Italy, with exposure to cross-functional teams.

Qualifications

• 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 ICH-GCP, regulatory requirements, and clinical research standards.

Responsibilities

• 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.

Skills

Leadership

Communication

Problem solving

ICH-GCP

Regulatory compliance

Monitoring & quality oversight

Tools

CTMS

Job description

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.

• competitive compensation
• health insurance
• pension
• car allowance where applicable
• 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 informationCollaborate 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
• 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 prato, toscana, it