Clinical Affairs Lead EU

  • Eysins, Switzerland
  • Full-time

Company Description

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage
diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

Job Description

  • Responsible for creating clinical strategy, planning and management of all Quotient EU clinical field trials related to MosaiQ including related management of potential contracted organizations conducting field trials in foreign countries.
  • In collaboration with the Finance & Administration, negotiate and administer all activities with potential field trial sites and or Contract Research Organizations concerning contracts and activities.
  • Working with the Contract Research Organizations, guide and assist the development of Electronic Data Capture database.
  • Coordinate clinical field trial development activities and strategies.
  • Lead in the development of clinical trial designs with internal resources and or Clinical Research Organizations.
  • Perform site initiations, monitoring visits, close out visits as required.
  • Manage, train, and monitor Clinical Research Associates in the production and administration of clinical study protocols

Qualifications

  • A relevant degree or professional qualification, Clinical Affairs Professional Society certification or advanced degree in clinical affairs desirable.
  • Significant specialist knowledge of clinical affairs as applied to in vitro diagnostic medical devices and instrumentation and an understanding of the operation of a medical device manufacturing establishment.
  • Ability to analyses information in a structured manner and to be able to prepare coherent technical reports.
  • Working knowledge of GMP, ISO 13485 and IVDD requirements and also knowledge of international regulatory agencies and submission processes is required.
  • Ability to work under pressure, meet deadlines and respond flexibly.
  • Ability to travel (approximately 25%) will be an essential part of this position.

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