European Clinical Project Lead – MedTech (Remote + Travel)

CILIATECH - Glaucoma Innovators; France; Remote; EUR 90,000 - 130,000; Full time

Job summary

CILIATECH - Glaucoma Innovators seeks a Senior Clinical Project Manager to lead European clinical studies from planning to close-out. You will translate development strategy into executable plans, timelines, budgets and risk registers while coordinating investigators, sites, CROs and vendors across Europe.

The role requires oversight of eTMF/EDC systems, data flow, and regulatory documentation, with travel across European sites and potential remote work from France, UK or Germany.

Qualifications

• Advanced degree in life sciences, clinical research, biomedical sciences, pharmacy, nursing or another relevant discipline.
• Significant experience managing multicentre clinical studies from setup through close-out.
• Experience in ophthalmology clinical trial execution and medical-device development.
• Experience managing multicentre European clinical investigations under EU MDR and applicable national requirements.
• Experience leading CRAs, CTAs, CROs, sites and clinical vendors.
• Experience managing study timelines, budgets, operational risks and essential documents.
• Strong knowledge of Good Clinical Practice, ISO 14155, EU MDR and European clinical-investigation requirements.
• Strong understanding of TMF/eTMF, EDC, monitoring, clinical data flow, audit readiness and inspection readiness.
• Ability to lead day-to-day study execution and resolve operational issues with autonomy.

Responsibilities

• Lead the day-to-day planning, set-up, operational execution and close-out of European clinical studies.
• Translate approved clinical development strategy and protocol requirements into integrated execution plans, timelines, budgets, resource plans, risk registers and study deliverables.
• Coordinate country and site feasibility, site selection, contracts, ethics and regulatory submission support, site activation and readiness tracking.
• Manage study progress, enrolment, milestones, dependencies, issues and corrective actions.
• Provide clear and concise reporting on clinical progress, timelines, budgets, risks and resource requirement.
• Act as the operational lead and primary day-to-day contact for investigators, study coordinators, CRAs, CROs and clinical vendors.
• Select, lead and coordinate the CRA network and assigned Clinical Trial Associate resources, as appropriate.
• Manage external vendors required for the execution of clinical activities.
• Oversee monitoring activities, site performance, protocol compliance, deviations, follow-up actions and study close-out activities.
• Coordinate investigator and site training readiness with the relevant scientific, medical and surgical-training resources.
• Lead the evaluation, selection, implementation and operational oversight of the eTMF, EDC and other clinical systems or service providers required for European studies.
• Oversee the preparation, review, collection and maintenance of essential clinical documents and project-level plans.
• Maintain operational audit and inspection readiness in collaboration with Quality.
• Ensure timely follow-up of documentation gaps, deviations and CAPA-related actions assigned to Clinical Operations.
• Coordinate data-management activities, data-quality follow-up, query resolution and database-readiness activities with internal teams and external provider.
• Lead clinical vendor and service-provider evaluation, selection recommendations, onboarding and day-to-day performance management.
• Manage and track approved study budgets, forecasts, purchase orders and invoices.
• Identify clinical operational risks early and define appropriate mitigation options.
• Escalate matters that may affect patient safety, quality, timelines, budgets, resources or study objectivese.

Skills

Clinical trial management

Ophthalmology trials

EU MDR experience

Vendor management

Cross-functional coordination

English proficiency

Autonomy

Data management

Education

Advanced degree in life sciences or related field

Master’s degree in clinical research or related field

Tools

eTMF

EDC

Job description

CILIATECH - Glaucoma Innovators seeks a Senior Clinical Project Manager to lead European clinical studies from planning to close-out. You will translate development strategy into executable plans, timelines, budgets and risk registers while coordinating investigators, sites, CROs and vendors across Europe.

The role requires oversight of eTMF/EDC systems, data flow, and regulatory documentation, with travel across European sites and potential remote work from France, UK or Germany.