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IVD Clinical Study Manager (remote - exp.in IVD is required)

  • Location:

    England

  • Contact:

    Amandine Planche

  • Job type:

    Contract

  • Contact phone:

    +32 10 68 53 30

  • Industry:

    Life Sciences, Biotechnology

  • Contact email:

    amandine_planche@oxfordcorp.com

Do you have experience in designing, planning and conducting clinical trials within IVD? Are you available to work fulltime for one of the most successful biotech companies? Let's connect for this existing opportunity!

Job Description

Our client is looking for a clinical project manager who could significantly contribute towards efficient/expedited launch of new or improved products. You will be accountable for the design, planning and conduct of clinical studies, including reporting results. You will be coordinating the efforts and activities of diverse internal and external stakeholders, ensuring compliance with organizational SOPs and all international regulations, while ensuring that all aspects of the clinical study are completed correctly and in a timely manner within budget. For this position, you will need to work independently and autonomously.

Responsibilities

  • Accountable for study design, strategy, planning (timeline and budget) for sponsored clinical studies, coordinating activities with stakeholders internally and externally and providing regular status reports
  • Accountable for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs
  • Accountable for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, troubleshooting, and prevention planning
  • Coordinating and supervising clinical monitoring team

Requirements

  • Minimum 2-3 years working experience with in vitro diagnostic devices company.
  • Working experience in Clinical Affairs/Operations and experience with diagnostic clinical studies
  • Good understanding of project management
  • Authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed Consent Documents
  • Proficient English oral and written communication

Benefits

  • Assignment for 12 months
  • Working schedule: full time
  • Locations: Barcelona - Spain, Hilden - Germany, Manchester - UK, German Town - USA

Existing right to work in Europe or USA required ( please read job spec in full before applying ).

Vacancy number: 17359