Senior Clinical Project Manager

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 objectives e

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

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