Clinical Trial Management Team Lead

vor 1 Monat

DomatEms, Graubünden, Schweiz Hamilton Medical AG Vollzeit
Job Title: Clinical Trial Management Team Lead

Hamilton Medical AG is seeking a highly skilled Clinical Trial Management Team Lead to oversee and coordinate all aspects of clinical trials related to our ventilation technology from inception to completion.

Key Responsibilities:
  • Lead, mentor, and develop the clinical trial organization at Hamilton Medical, fostering a collaborative and high-performance culture.
  • Provide guidance and support to team members on clinical trial processes, regulatory requirements, and company policies.
  • Conduct regular performance reviews and develop training plans for team members.
  • Develop trial strategies and ensure the successful execution of clinical studies from inception to completion.
Clinical Trial Portfolio Oversight:
  • Oversee the planning, implementation, and management of clinical trial portfolio (mainly European and US trials), including protocol development, site selection, and patient recruitment.
  • Develop and manage trial portfolio budget, timelines, and resources.
Regulatory Compliance and Quality Assurance:
  • Ensure trials are conducted in alignment with our product innovation strategy, regulatory requirements, company SOPs, and ethical standards in compliance with GCP, ISO 14155, MDR, and other relevant regulations.
  • Monitor regulatory requirement updates.
  • Liaise with regulatory authorities as needed.
  • Develop and update SOPs related to clinical trial management.
Data Management and Reporting:
  • Manage and develop the overall clinical data management: data collection, quality, and analysis processes to ensure data integrity and accuracy.
  • Prepare regular progress reports for senior management and regulatory bodies.
  • Ensure timely and accurate reporting of adverse events and deviations.
Stakeholder Communication:
  • Serve as the primary point of contact for investigators, study sites, and external vendors (e.g., CROs).
  • Facilitate communication with other internal departments, including R&D, regulatory affairs, and clinical affairs.

Requirements:

  • Master's degree in life sciences, engineering, or a related field.
  • Minimum of 8 years of experience in clinical trial management within the medical device industry, with at least 4 years in a leadership role.
  • Track record of successful talent recruitment and development.
  • In-depth knowledge of GCP, ISO 14155, and regulatory requirements (MDR) for medical devices.
  • 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.

Join our team at Hamilton Medical AG and contribute to the development of innovative medical devices that improve people's lives.

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