Clinical Trial Management Team Lead

vor 2 Wochen

DomatEms, Graubünden, Schweiz Hamilton Vollzeit

As a Clinical Trial Management Team Lead at Hamilton, you will be responsible for overseeing and coordinating all aspects of clinical trials related to our ventilation technology from inception to completion.

The Clinical Trial Management Team is an integral part of CRI, our interdisciplinary clinical research and innovation department, which is responsible for the development and validation of new clinical functionalities of all our products, including ventilators and digital software solutions.

The generated clinical data is crucial for regulatory approvals, Post-Market Clinical Follow-up and for future data-driven initiatives, including machine learning algorithm development and validation.

Key Responsibilities

Leadership and Team Management

  • Leading, mentoring and developing the clinical trial organization at Hamilton, fostering a collaborative and high-performance culture
  • Providing guidance and support to team members on clinical trial processes, regulatory requirements and company policies
  • Conducting regular 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 European and US trials), including protocol development, site selection, and patient recruitment
  • Developing and managing trial portfolio budget, timelines, and resources

Regulatory Compliance and Quality Assurance

  • Ensuring 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
  • Monitoring regulatory requirement updates
  • Liaising with regulatory authorities as needed
  • Developing and updating SOPs related to clinical trial management

Data Management and Reporting

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

Requirements

Master's degree in life sciences, engineering or a related fieldMinimum of 8 years of experience in clinical trial management within medical device industry, with at least 4 years in a leadership roleTrack record of successful talent recruitment and developmentIn-depth knowledge of GCP, ISO 14155, and regulatory requirements (MDR) for medical devicesProven track record of managing clinical trials from initiation to completionPeople's lead mentality, strong leadership, organizational, and communication skillsMotivation to act as an architect of an effective and efficient CTM organization, interpreting this task as a challenge and attractive opportunityAbility to manage multiple projects and prioritize effectivelyProficiency in clinical trial management software and clinical data managementCertification in clinical research, PhD and FDA experience are a plus

At Hamilton, we offer a motivating working environment, various leisure activities, and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. If you share our values and feel at home in a cooperative and down-to-earth environment, we would be happy to receive your application.

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