Team Lead Clinical Trial Management 80 - 100 % (f/m/d)
True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950.
We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.
Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan our solutions cover a multitude of patient groups, applications and environments.
How you can make a difference :
The Clinical Trial Management Team Lead will be responsible for overseeing and coordinating all aspects of clinical trials related to Hamilton Medical's ventilation technology from inception to completion.
The CTM Team is an integral part of CRI, Hamilton Medical’s interdisciplinary clinical research and innovation department, which is responsible for the development and validation of new clinical functionalities of all Hamilton Medical 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 Medical, 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
That’s what you bring along :
Master’s degree in life sciences, engineering or a related field
Minimum of 8 years of experience in clinical trial management within 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
Learn more about career opportunities at Hamilton at .
Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions.
Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered.
Interested? Then apply online using the "Apply now" button. If you have any questions, please contact us at with the following details :
Reference : JR-4287-fjm / Contact : Ilaria Cerullo
Applications by post or e-mail can unfortunately not be considered.