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Clinical Affairs Associate
Quotient - Eysins
16.05.2019 | Employee | 100%

Clinical Affairs Associate

READY TO RESHAPE

TRANSFUSION
DIAGNOSTICS?

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. MosaiQ , Quotient's proprietary multiplex microarray technology, offers 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 Quotient believes 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.

Clinical Affairs Associate

JOB DESCRIPTION

The Clinical Affairs Associate will be responsible for contributing to the successful execution of assigned clinical field trials within budget and in conformance with global regulations and internal policies and procedures. His/her main activities will be:

  • Be responsible for creating clinical strategy, planning and management of Quotient clinical field trials related to MosaiQ ; management of potential contracted organizations conducting field trials abroad;
  • Participate in the negotiation and administration of contracts and field trials activities with potential field trial sites and related
  • Manage together with regulatory affairs, the completion of all clinical aspects of regulatory submissions;
  • Coordinate clinical field trial development activities and strategies
  • Lead in the development of clinical trial designs with internal resources and or Clinical Research
Organizations
- Monitor and analyze clinical trial data and direct the disposition of results and ad-hoc reports to Sales Organization and Management
- Perform site initiations, monitoring visits, close out visits as required

QUALIFICATIONS & EXPERIENCE REQUIRED

  • A scientific or relevant degree or professional qualification in Clinical Affairs or equivalent
  • Specialist knowledge of clinical affairs as applied to in vitro diagnostic medical devices including instrumentation; understanding of the operation of a medical device manufacturing establishment
  • Previous experience in a clinical laboratory testing environment
  • Working knowledge of GMP, ISO 13485 and IVDD requirements
  • Excellent analyzing and reporting skills
  • Ability to work under pressure, meet deadlines and respond flexibly
  • Team player and effective communication at all organizational levels
  • Fluent in English. Proficient in one of the primary European languages (French, German or Spanish)
  • Ability to travel (approximately 25%)

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