Clinical Study Manager (Selution)

Overview

About Us:

MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let's improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

We are seeking a Clinical Study Manager to join our clinical study team to support randomized, multi-center IDE clinical trials within our Clinical program. This research is the top priority for MedAlliance, allowing you the chance to play a pivotal role in the advancement of our organizational goals and in improving patient care. In this position, you will oversee the successful execution and completion of the clinical trial from initiation to conclusion.

Responsibilities

• Lead and Coordinate: Oversee the coordination and management of the clinical trial, ensuring all teams and departments work synergistically.
• Compliance and Regulation: Ensure adherence to industry standards, both US and OUS regulations, and compliance with study Protocol, and local regulations.
• Trial Master Files (TMFs): Oversee the management and maintenance of internal TMFs.
• Stakeholder Engagement: Organize and lead Steering Committee events, ensuring that the objectives are clearly communicated and achieved. Oversee content preparation for these meetings.
• Reporting: Prepare and present dashboards, reports, and other tracking mechanisms to provide insight into the study's progress.
• Vendor Management: Collaborate with the CRO and Core Labs and additional vendors, ensuring the deliverables are of the highest quality.
• Investigator and Coordinator Meetings: Lead and oversee organization and content preparation for key meetings with investigators and study coordinators.
• Issue Management: Monitor potential risks or issues, ensuring timely escalation to the appropriate channels.

Qualifications

• A minimum of 8 years of experience in the medical device space, preferably in a managerial role, with a robust understanding of ICH and GCP guidelines.
• Experience in leading an IDE clinical study is a plus.
• Familiarity with cardiovascular clinical studies is advantageous.
• A Bachelor's degree is essential.
• Demonstrated ability to communicate efficiently and effectively with various stakeholders.
• Proven experience operating independently with high energy.
• Strong organizational skills with an emphasis on detail and output accuracy.
• Ability to collaborate across multiple time zones, including Europe.
• Fluent in English.