Clinical Project Manager

Clinical Project Manager – Basel, Switzerland

Job Responsibilities

  • Manage clinical investigations to ensure timely delivery of project objectives within the scope of the clinical investigation strategy and within the approved budget.
  • Provide input and review into the development of the Clinical Investigation Protocol (CIP) and final Clinical Investigation Report (CIR) developed by the Clinical Research Program team.
  • Develop relevant documents to plan, execute and complete the investigation, including the Clinical Investigation Project Plan (CIPP), Investigator Brochure (IB), Case Report Form (CRFs) and forecast the budget.
  • Ensure compliance with company SOPs and applicable regulations, such as Good Clinical Practice (GCP) as outlined in the international standard ISO14155 and EU General Data Protection Regulation (GDPR).
  • Plan Site Initiation Visits (SIV), Monitoring Visits (MV) and Close out Visits (COV) and coordinate with monitoring resources from external Clinical Research Organizations. Define meeting agendas and training content.
  • Continuously communicate project progress, outcomes, risks and plans for mitigation to internal stakeholders as well as to relevant investigators. Host Investigator Meetings and hold Milestone meetings with project sponsors.
  • Support and contribute to papers or presentations/posters at scientific conferences based on investigation outcomes and align with market claims.

Requirements

  • PhD degree in life sciences or equivalent
  • Qualified knowledge of Medical Device Regulations on conduct of clinical investigations (ISO14155, GCP, EU MDR)
  • ≥ 2 years of experience as Clinical Project Manager or equivalent in medical device industry
  • Advanced knowledge of implantable hearing solutions, audiology and otology
  • Experience working with Key Opinion Leaders in the field of hearing
  • Experience in a global, cross-functional environment including remote partners
  • Knowledge of the implant field as well as familiarity with Nucleus products
  • Strong scientific publication record
  • Master in planning, tracking and communication software, such as MS Project, JIRA and Confluence
  • Strong knowledge of electronic database systems
  • Good knowledge of additional European languages 

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading specialist life science recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

 

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