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For our client, a leading International MedTech company with Eropean headquarter in Chur, GR, Switzerland, we are looking for a

Team Lead Clinical Trial Management (6147)

80-100%

The Clinical Trial Management Team Lead will be responsible for overseeing and coordinating all aspects of clinical trials related to the client's ventilation technology from inception to completion, and will be part of the Interdisciplinary Clinical Research and Innovation deaprtment.

Key Responsibilities

Leadership and Team Management

  • Leading, mentoring and developing the clinical trial organization, fostering a collaborative and high-performance culture
  • Providing guidance and support to team on clinical trial processes, RA requirements and company policies
  • Conducting performance reviews and developing training plans for team members
  • Developing trial strategies and ensuring the successful execution of clinical studies from inception to completion
  • ​​​

Clinical Trial Portfolio Oversight

  • Overseeing the planning, implementation, and management of clinical trial portfolio (mainly EU & US), incl protocol development, site selection, and patient recruitment
  • Developing and managing trial portfolio budget, timelines, and resources

Regulatory Compliance and Quality Assurance

  • Ensuring trials are in alignment with product innovation strategy, RA requirements, company SOPs and ethical standards in compliance with GCP, ISO 14155, MDR and other relevant regulations
  • Monitoring regulatory requirement updates
  • Liaising with regulatory authorities
  • Developing and updating SOPs related to clinical trial management

Data Management and Reporting

  • Managing and developing the overall clinical data management: collection, quality, and analysis processes to ensure data integrity and accuracy
  • Preparing progress reports for senior management and regulatory bodies
  • Ensuring timely and accurate reporting of adverse events/deviations

Stakeholder Communication

  • Serving as the primary point of contact for investigators, study sites, and external vendors (e.g. CROs)
  • Facilitating communication with other internal departments, including R&D, regulatory affairs, and clinical affairs

That’s what you bring along:

  • Master’s degree in life sciences, engineering or a related field
  • >8y of experience in clinical trial management within medical device industry, >4y in a leadership role
  • Track record of successful talent recruitment and development
  • In-depth knowledge of GCP, ISO 14155, and regulatory requirements (MDR)
  • Proven track record of managing clinical trials from initiation to completion
  • People’s lead mentality, strong leadership, organizational, and communication skills
  • Motivation to act as an architect of an effective and efficient CTM organization, interpreting this task as a challenge and attractive opportunity
  • Ability to manage multiple projects and prioritize effectively
  • Proficiency in clinical trial management software and clinical data management
  • Certification in clinical research, PhD and FDA experience are a plus

Interested? Contact us!

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