Clinical Research Manager

Trial Form Support; Varese; Teletrabalho; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Pension

Car allowance where applicable

Competitive compensation

Resumo da oferta

Trial Form Support is seeking a Clinical Research Manager in Ophthalmology to lead multi-country clinical operations within a global CRO framework. You will ensure ICH-GCP compliance, deliver trials on time, and partner with PMs, CRAs, sponsors, and sites, enabling innovative ophthalmic therapies and patient outcomes.

The role offers home-based work across Europe, including Poland, Spain, or Italy. Leverage your 5+ years in clinical research with on-site CRA/CRM experience to manage day-to-day

Qualificações

• 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.

Responsabilidades

• 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.
• Review CTMS data for accurate country/site/subject information.

Conhecimentos

Leadership

Communication

Problem solving

ICH-GCP

Regulatory compliance

Monitoring quality

Team coaching

Ferramentas

CTMS

Descrição da oferta de emprego

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 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
• 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 • varese, lombardia, it