Clinical Research Manager (Roma)

Clinical Research Manager (Roma)

10 ott
|
Altro
|
Roma

10 ott

Altro

Roma

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

📌 Clinical Research Manager (Roma)
🏢 Altro
📍 Roma

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