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Director Clinical Operations EMEA

Job in Gothenburg, Dawson County, Nebraska, 69138, USA
Listing for: Cochlear
Full Time position
Listed on 2026-07-18
Job specializations:
  • Healthcare
    Healthcare Management
Job Description & How to Apply Below
Location: Gothenburg

Director Of Clinical Operations – Emea

Change 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:

  • 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…
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