Senior Clinical Project Manager - Europe

The aim of the Senior Clinical Project Manager is to lead the operational planning and delivery of Ciliatech-sponsored European clinical studies.

Location: Preference for candidates based in France, ideally in Lyon with the ability to work regularly from our office. Remote working can also be considered for candidates based in France, the UK or Germany.

RESPONSIBILITIES

European Clinical Study Planning & Execution

• Lead the day-to-day planning, set-up, operational execution and close-out of Ciliatech-sponsored 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

Clinical Operations & Site Management

• 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

Clinical Systems, Documentation & Data Flow

• 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

Vendor, Budget & Risk Management

• 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

Cross-Functional Coordination

• Work closely with Clinical Research Science, Medical, Regulatory, Quality, R&D, Finance and Legal functions to deliver study milestones

• Provide operational input into protocols, informed consent forms, monitoring plans, data-management plans, clinical study reports and regulatory documentation

• Contribute lessons learned and practical recommendations to improve clinical processes and build a scalable European clinical infrastructure

• Support the delivery of clinical investigations in compliance with applicable quality and regulatory requirements

Profile

Required Skills/Experience

• Advanced degree in life sciences, clinical research, biomedical sciences, pharmacy, nursing or another relevant discipline

• Significant experience managing multicentre clinical studies from set-up through close-out

• Experience in ophthalmology clinical trial execution and medical-device development

• Experience managing multicentre European clinical investigations under the 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

• Strong vendor, site and stakeholder-management skills

• Ability to manage and develop employees, contractors and distributed clinical teams

• Clear written and verbal communication skills, including concise management reporting

• Professional fluency in English

Preferred Skills/Experience

• Master’s degree or recognised project-management qualification in clinical research or a related field

• Experience in glaucoma or implantable ophthalmic medical devices

• Experience bringing sponsor-led clinical operations in-house or building clinical infrastructure in an early-stage MedTech company

• Experience managing studies involving approximately 12 sites, or multicountry studies of comparable complexity

• Experience selecting and implementing eTMF, EDC or other clinical systems

• Project-management certification

• Working knowledge of an additional European language

• Existing network of ophthalmology investigators, CRAs or clinical service providers in Europe