Team Lead Clinical Trial Management 80 - 100 % (f/m/d), Domat/Ems

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Team Lead Clinical Trial Management 80 – 100 % (f/m/d), Domat/Ems

Client: Hamilton

Location: Domat/Ems

Job Category: Other

Job Reference: c64ceb590778

Job Views: 12

Posted: 19.02.2025

Expiry Date: 05.04.2025

Job Description:

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:

1. Leading, mentoring and developing the clinical trial organization at Hamilton Medical, fostering a collaborative and high-performance culture.
2. Providing guidance and support to team members on clinical trial processes, regulatory requirements and company policies.
3. Conducting regular performance reviews and developing training plans for team members.
4. Developing trial strategies and ensuring the successful execution of clinical studies from inception to completion.

Clinical Trial Portfolio Oversight:

1. Overseeing the planning, implementation, and management of clinical trial portfolio (mainly European and US trials), including protocol development, site selection, and patient recruitment.
2. Developing and managing trial portfolio budget, timelines, and resources.

Regulatory Compliance and Quality Assurance:

1. 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.
2. Monitoring regulatory requirement updates.
3. Liaising with regulatory authorities as needed.
4. Developing and updating SOPs related to clinical trial management.

Data Management and Reporting:

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

Stakeholder Communication:

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

That’s what you bring along:

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

Learn more about career opportunities at Hamilton. 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 with the following details:

Reference: JR-4287-fjm/Contact: Ilaria Cerullo

Applications by post or e-mail can unfortunately not be considered.

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