Director Clinical Operations EMEA

Cochlear Limited; Antwerpen; Sur place; EUR 180 000 - 240 000; Plein temps

Résumé du poste

Cochlear Limited in Europe seeks a Director of Clinical Operations – EMEA to shape and deliver the regional strategy for Cochlear-sponsored clinical investigations across multiple countries. You will lead a high-performing team, partner with regulatory, quality, and sites, and ensure trials are on time, within budget, and compliant with GCP, ISO 14155, MDR/IVDR.

The role requires 8–10 years in clinical operations, with leadership experience, strong budgeting skills, and a track record managing

Qualifications

• 8–10 years of progressive clinical operations experience, with leadership exposure.
• Strong knowledge of Good Clinical Practice (GCP), ISO 14155, MDR/IVDR.
• Experience leading multi-country clinical investigations in pharma or medical devices.
• Proven ability to manage budgets, resources and stakeholder expectations.
• Experience developing and implementing regional clinical operations strategies.

Responsabilités

• Develop and implement the Clinical Operations strategy for study execution across Europe, the Middle East and Africa (EMEA).
• Lead planning and allocation of regional resources to match business priorities.
• Oversee study start-up, site activation, enrolment progress and site performance with proactive issue resolution.
• Manage investigator, site, CRO and vendor relationships, including contracting and governance.
• Drive initiatives to standardise processes, improve efficiency and optimise vendor relationships.
• Ensure regional study processes comply with Cochlear’s Quality Management System, GCP, ISO standards, MDR/IVDR and national regulations.
• Act as regional contact for regulatory inspections, audits and ethics committee interactions.

Connaissances

Leadership

Budget management

Regulatory knowledge

Cross-functional collaboration

Strategic planning

Data-driven decisions

Formation

Bachelor’s degree in a scientific or health-related discipline

Description du poste

## Director Clinical Operations EMEAApplylocations: Goteborg, Sweden: Mechelen, Belgiumtime type: Full timeposted on: Posted Todayjob requisition id: R-623757Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.The Director of Clinical Operations – EMEA will develop and implement the regional clinical operations strategy and lead the delivery of Cochlear-sponsored clinical investigations across EMEA. This role is accountable for ensuring high-quality clinical research delivery, while maintaining regulatory excellence, operational efficiency, and financial accountability.Leading a high-performing Clinical Operations team, and partnering closely with regional stakeholders, sites and vendors, the role will align study execution plans with business objectives, drive innovation in clinical operations practices, optimise resources and performance, and strengthen Cochlear’s reputation as a research partner of choice in the hearing implant industry.Ultimately, you will contribute to the delivery of high-quality clinical research, operational excellence, and meaningful impact for patients, through the following key accountabilities:**Key Accountabilities:*** 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**About You:*** 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%**Desired Skills:*** Master’s degree, MBA or Ph.D. in a scientific, health or business discipline* Broad understanding of medical devices or instrumentation used in the hearing implant therapy area* Experience across additional business areas such as Operations, Quality Assurance, Regulatory Affairs, Project Management or Commercial* Understanding of emerging clinical operations trends, including decentralised trials, digital health technologies, patient-centric research and risk-based monitoring approaches* Experience successfully building and developing regional clinical operations teams* Established relationships with investigators, clinical research professionals and regulatory authorities across EMEA* Additional language skills highly valued**Development value of this role:*** Lead clinical operations across a diverse geographic region with multiple regulatory jurisdictions, healthcare systems and cultural contexts* Serve as a critical bridge between Global Clinical Operations strategy and regional execution* Gain significant visibility with senior management, regional commercial teams and external Cochlear customers across EMEA* Represent Cochlear at regional and international forums and contribute to global clinical strategy and process development* Deepen expertise in regional healthcare systems, regulatory frameworks and market dynamics while making a meaningful impact on Cochlear’s ability to bring life-changing hearing solutions to patients