Develop and implement the Clinical Operations strategy for study execution across EMEA, ensuring studies are delivered on time, within budget, and to high quality standards
Lead the planning and allocation of regional resources, ensuring workload is effectively distributed and aligned to business priorities
Oversee study start-up, site activation, enrolment progress and site performance, using metrics to identify and resolve issues proactively
Manage investigator, site, CRO and vendor relationships, including contracting frameworks, performance governance, escalation and continuous improvement
Drive operational efficiency initiatives, identifying opportunities to standardise processes, leverage technology, optimise vendor relationships and reduce waste
Manage regional clinical investigation budgets and seek opportunities to improve the cost-effective use of resources while maintaining study quality and compliance
Build organisational capability by assessing talent, identifying capability gaps, supporting development plans and setting clear performance expectations
Ensure regional clinical study processes comply with Cochlear’s Quality Management System, Good Clinical Practice, relevant ISO standards, MDR/IVDR and applicable national regulations
Act as the regional point of contact for regulatory inspections, audits and ethics committee interactions, and ensure safety reporting compliance across applicable requirements

Bachelor’s degree in a scientific or health-related discipline
8–10 years of progressive clinical operations experience within the pharmaceutical or medical device industries, including at least 3 years in leadership roles
Proven experience managing clinical operations across multiple countries and regulatory jurisdictions
Strong track record of planning and executing complex, multi-site clinical investigations
Deep knowledge of Good Clinical Practice, ISO 14155, MDR/IVDR and applicable regional/country-specific clinical research requirements
Experienced in people management and development, with the ability to build and lead high-performing teams
Strong financial acumen, including budget development, financial management, forecasting and resource optimisation
Demonstrated ability to translate organisational strategy into operational execution, navigate ambiguity and deliver change
Collaborative and influential communicator, able to partner effectively with Regulatory Affairs, Quality, Commercial, sites, investigators, vendors and other external partners
Strong analytical skills, with the ability to use data, metrics and dashboards to drive decision-making and continuous improvement
Cultural intelligence and the ability to work effectively across diverse organisational and cultural contexts
Fluent in English, with willingness and ability to travel internationally approximately 20%

Director, Clinical Operations – EMEA

Key skills