Clinical Trial Management Leader for Medical Device Innovation
vor 2 Wochen
At Hamilton Medical AG, we're driven by a passion for innovation that improves lives. With over 70 years of experience in the health sector, we've established ourselves as a pioneer in ventilator technology, automated pipetting, sample management, and process sensors. Our commitment to pushing boundaries has led to the development of intelligent ventilators that cater to diverse patient needs and environments.
Job DescriptionWe're seeking an exceptional Clinical Trial Management Leader to join our interdisciplinary clinical research and innovation department, CRI. As a key member of this team, you'll oversee the entire lifecycle of clinical trials related to our ventilation technology. From inception to completion, your strategic leadership and expertise will ensure the successful execution of our clinical studies.
Key Responsibilities- Leadership and Team Management
- Lead, mentor, and develop a high-performing clinical trial organization, fostering a collaborative culture that encourages growth and innovation.
- Provide guidance and support to team members on clinical trial processes, regulatory requirements, and company policies.
- Conduct regular performance reviews and create tailored training plans to enhance team members' skills.
- 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 portfolios, including protocol development, site selection, and patient recruitment.
- Develop and manage trial portfolio budgets, 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.
- Monitor regulatory requirement updates and liaise with regulatory authorities as needed.
- Develop and update SOPs related to clinical trial management.
- Data Management and Reporting
- Manage and develop overall clinical data management processes, ensuring 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
- Act as the primary point of contact for investigators, study sites, and external vendors.
- Facilitate communication with internal departments, including R&D, regulatory affairs, and clinical affairs.
- Master's degree in life sciences, engineering, or a related field.
- Minimum 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 for medical devices.
- Proven track record of managing clinical trials from initiation to completion.
- Strong leadership, organizational, and communication skills.
- 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.
As a Clinical Trial Management Leader at Hamilton Medical AG, you'll be part of a dynamic team that values innovation, collaboration, and growth. Our company offers a motivating work environment, various leisure activities, and modern working conditions. We encourage open communication and a pleasant working environment, where your skills are valued and innovative ideas are fostered.
Estimated SalaryWe offer an estimated salary of CHF 120,000 - 150,000 per year, depending on location and experience.
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