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Case Study

Growing the EU team of a US-based medical device company ahead of a pivotal trial launch

Male shaking hands with a female in a business setting

Case Study

Growing the EU team of a US-based medical device company ahead of a pivotal trial launch

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Specialisms

Clinical Operations

Clinical Development

Medical

Regulatory Affairs

  • At the forefront of innovation and hypertension technology and on the cusp of launching the first EU trial of their lead product, this medical device start-up approached us in December 2017 to build out their entire European function and to offer guidance on the ideal infrastructure of their teams.

  • Being a small company of fewer than 15 employees at the time of engagement, the client was looking for a partner that could act as an extension of their permanent team, who could use their own expertise and sector knowledge when sourcing candidates, putting forward potential hires and advising on team structure.

  • Without feet on the ground locally, the client also needed support with onboarding candidates at such a large scale, as well as with navigating local compliance regulations within the six countries the trial was set to span. They were initially looking for a number of contractors across clinical, data management, safety and medical writing departments for a trial launch date in September 2018.

Project Timeline
  • DEC 2017

  • SEPT 2018

  • OCT 2018

  • JAN 2019

  • JUN 2019

  • SEPT 2019

  • JAN 2020

  • Initial Engagement

    Initial Engagement

    ​We are engaged for the setup of the EU trial, and begin working on a variety of contract positions within clinical operations, regulatory, medical writing and commercial.

  • 13 Contractors Appointed

    13 Contractors Appointed

    ​The first placements are appointed and begin work on the trial; 13 contractors to oversee operations across clinical, regulatory, data management, safety and medical writing departments.

  • Further Support in the US

    Further Support in the US

    ​We are asked to provide further support as the trial begins. Two permanent positions at director level in the States, and various contractors for both the US and EU.

  • Major Funding and First Permanent Hires

    Major Funding and First Permanent Hires

    After securing Series D funding amounting to over $70m, four candidates are placed into permanent positions. This includes a Director of Clinical Operations, a Director of Clinical Program Management and two CRAs.

  • Post-Market Trial Success

    Post-Market Trial Success

    ​The post-market clinical trial demonstrates success for the device, and we appoint two Field Clinical Specialists for the EU and US sites respectively.

  • Commercialisation Support

    Commercialisation Support

    We source a Freelance Marketing Consultant to support the product commercialisation effort in the US, and the client's post-market trial demonstrates efficacy in resistant hypertension.

  • Further Commercial Support

    Further Commercial Support

    We appoint a Reimbursement Consultant, appointed to establish the pricing and reimbursement strategy in various European markets.

Over an 8-month period, we took the client from having no EU presence to having 13 contractors across clinical, regulatory, data management, safety and medical writing departments in time for their Phase II trial launch in September 2018.

  • Since our success with the initial requirement, we've been engaged to provide continual support in further growing their EU teams as well as their already established presence in the US.

  • In a partnership that now spans more than three years, we have facilitated the placement of 45 contract and permanent staff across 8 countries. We also manage the ongoing legal and regulatory requirements of their contract workforce, with routine visa, insurance and right to work checks handled by our in-house contractor compliance department.

Placement Map

Placement Maps

USA:

Perm Placements
• Director of Clinical Program Management
• Field Clinical Specialist
• Senior Clinical Research Associate
• Clinical Research Associate (x2)

Contract Placements
• Medical Safety Officer
• Safety Scientist
• Marketing Consultant
• Clinical Research Associate (x2)

UK:

Permanent Placements
• Director of Clinical Operations & Regulatory

Contract Placements
• Clinical Trial Manager
• Clinical Data Manager (x2)
• Medical Safety Officer
• Medical Writer
• Clinical Research Associate

France:

Permanent Placements
• Regulatory Affairs Coordinator

Contract Placements
• Clinical Project Manager
• Senior Clinical Research Associate
• Clinical Trial Associate
• Clinical Research Associate

Germany:

Contract Placements
• Field Clinical Specialist
• Senior Clinical Research Associate
• Clinical Research Associate

Netherlands:

Contract Placements
• Senior Clinical Research Associate
• Clinical Research Associate

Belgium:

Contract Placements
• Medical Writer
• Clinical Research Associate (x2)

Czech Republic:

Contract Placements
• Clinical Research Associate

Sweden:

Contract Placements
• Clinical Research Associate (x2)

The team has been very sensitive about ensuring that they are in contact with us only when we need them to be. They have not oversold themselves and the work speaks for itself. We have had an excellent success rate in terms of candidates sent to us.

We are very judicious when it comes to hiring, and we have a strict selection process. SEC has recognised this when filtering, interviewing and making suggestions about key hires. We aren't spending too much time in the process, and we've had a great experience with th epeople we've brought on to date. That speaks volumes about the integrity of SEC, as well as the contractors they provide, so we are very happy.

VP of Clinical and Regulatory

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