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 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 5 years of experience in the medical device space, with a managerial or leadership role for at least 3 years,

Robust understanding of ICH and GCP guidelines

Experience in leading an IDE clinical study is a plus

Familiarity with cardiovascular clinical studies is advantageous, in the Coronary space, a plus

A Bachelor’s degree is preferred, or relevant and equivalent experience

Demonstrated ability to communicate efficiently and effectively with various stakeholders

Proven experience operating independently with high energy

Able to balance multiple priorities and multi-task

Strong organizational skills with an emphasis on detail and output accuracy

Ability to collaborate across multiple time zones, including Europe

Familiarity with EDC, eTMF, CTMS and relevant clinical systems

Core Lab / Imaging experience a plus

Fluent in English, bi-lingual a plus

LI-JB1

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants.

At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives.

Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity.

All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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Job Locations US-CA-Irvine

ID 2024-3176

Category Clinical

Position Type Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment.

We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves.

Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success.

Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities.

If you need assistance or an accommodation due to a disability, please contact [email protected]