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

The role will translate approved clinical development strategy and protocol requirements into executable study plans, timelines, budgets, resource plans and operational deliverables.

The Senior Clinical Project Manager will act as the operational lead for investigators, sites, CRAs, CROs and clinical vendors. The role combines clinical study management, site and vendor oversight, clinical systems implementation, budget management and cross-functional coordination.

This position is suited to an experienced clinical research professional who can lead complex multicentre medical-device studies with autonomy while working closely with scientific, medical, regulatory, quality and operational stakeholders.

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.

Mobility: Ability to travel independently to clinical sites and meetings with investigators, CROs and other study partners when required.

Travel readiness: Regular European travel will be required to support study start-up, site oversight, investigator meetings, vendor activities and key study milestones. Occasional international travel may also be required.

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