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Senior Clinical Project Manager
CILIATECH - Glaucoma Innovators. Lead the day-to-day planning, set-up, operational execution and close-out of Ciliatech-sponsored European clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing multicentre clinical studies, including operational execution, budget management, and compliance with EU MDR and Good Clinical Practice. Proficient in coordinating clinical trial resources, vendor management, and ensuring audit and inspection readiness.
Highest-signal resume keywords
Clinical Study ManagementGood Clinical PracticeEU MDR ComplianceVendor ManagementETMF/EDC Implementation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ExecutionBudget ManagementRisk ManagementData ManagementStudy Timeline ManagementProtocol DevelopmentSite SelectionRegulatory SubmissionOperational PlanningMonitoring Compliance
Soft Skills
Clear CommunicationStakeholder ManagementTeam LeadershipProblem SolvingAutonomy
Tools & Technologies
ETMFEDCClinical SystemsMonitoring ToolsData Quality Tools
Certifications & Qualifications
Project Management CertificationAdvanced Degree in Life Sciences
Industry Keywords
Ophthalmology Clinical TrialsMedical Device DevelopmentMulticentre StudiesClinical ResearchEuropean Clinical Investigation
About the role
Key responsibilities & impact- Lead the day-to-day planning, set-up, operational execution and close-out of Ciliatech-sponsored European clinical studies
- Translate clinical development strategy and protocol requirements into 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
- Report on clinical progress, timelines, budgets, risks and resource requirements
- Act as operational lead and primary contact for investigators, study coordinators, CRAs, CROs and clinical vendors
- Select, lead and coordinate CRA and Clinical Trial Associate resources
- Manage external vendors and oversee monitoring, site performance, protocol compliance, deviations, follow-up actions and study close-out
- Coordinate investigator and site training readiness
- Evaluate, select, implement and oversee eTMF, EDC and other clinical systems
- Maintain essential clinical documents, project-level plans, audit readiness and inspection readiness
- Follow up on documentation gaps, deviations and CAPA-related actions
- Coordinate data management, data-quality follow-up, query resolution and database readiness
- Lead vendor evaluation, selection recommendations, onboarding and performance management
- Manage study budgets, forecasts, purchase orders and invoices
- Identify and mitigate operational risks and escalate matters affecting patient safety, quality, timelines, budgets, resources or study objectives
- Collaborate with Clinical Research Science, Medical, Regulatory, Quality, R&D, Finance and Legal
- Provide operational input into protocols, informed consent forms, monitoring plans, data-management plans, clinical study reports and regulatory documentation
- Contribute lessons learned and recommendations to improve clinical processes and build scalable European clinical infrastructure
- Support compliant delivery of clinical investigations
Requirements
What you’ll need- 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
- Regular European travel required; occasional international travel may be required
- Preferred: Master’s degree or recognised project-management qualification in clinical research or a related field
- Preferred: Experience in glaucoma or implantable ophthalmic medical devices
- Preferred: Experience bringing sponsor-led clinical operations in-house or building clinical infrastructure in an early-stage MedTech company
- Preferred: Experience managing studies involving approximately 12 sites, or multicountry studies of comparable complexity
- Preferred: Experience selecting and implementing eTMF, EDC or other clinical systems
- Preferred: Project-management certification
- Preferred: Working knowledge of an additional European language
- Preferred: Existing network of ophthalmology investigators, CRAs or clinical service providers in Europe
Benefits
Comp & perks- Fully remote working option for candidates based in France, the UK or Germany
- Ability to work regularly from the Lyon office for candidates based in France
- Regular European travel and occasional international travel opportunities
- Opportunity to lead complex multicentre medical-device studies with autonomy
- Cross-functional collaboration with scientific, medical, regulatory, quality and operational stakeholders