Senior Clinical Operations Manager

2 weeks ago


Chicago, Illinois, United States Gateway Recruiting Full time
Position Overview
The Company is actively looking for a Senior Clinical Operations Manager to oversee clinical trials across Europe.

This role reports directly to the R&D manager and is crucial for the operational management and execution of clinical trials related to medical devices.

The Senior Clinical Operations Manager will ensure that all clinical studies are conducted in compliance with Good Clinical Practices and relevant regulatory requirements.

Key Responsibilities
- Lead the management of assigned clinical trials, ensuring adherence to timelines and project goals.
- Oversee the initiation, enrollment, and completion phases of clinical studies.
- Manage the selection and setup of study sites, including the preparation of necessary materials and submissions.
- Ensure accountability for daily study operations in accordance with contractual obligations and applicable regulations.
- Provide input on study protocols, data analysis plans, and final reports as necessary.
- Act as the primary contact for operational issues and deliverables related to the study.
- Maintain comprehensive knowledge of the study protocol and therapeutic areas involved.
- Build and sustain strong relationships with site investigators and key opinion leaders.
- Conduct regular site visits for engagement and oversight.
- Support the administrative functions of the clinical department.
Qualifications
- Bachelor’s degree in a health-related discipline; advanced degree preferred.
- Minimum of 3 years’ experience in the medical device sector.
- At least 3 years in Clinical Affairs or as a field clinical specialist.
- Familiarity with catheter lab and operating room environments.
- Experience with mid-scale pivotal trials in the US or EU.
- Exceptional written and verbal communication skills in English.
- Strong organizational and technical abilities.
- Knowledge of CT reading and ECG analysis is a plus.
- Willingness to travel internationally up to 20%.
Personal Attributes
- Excellent communication, presentation, and interpersonal skills.
- Ability to work independently and collaboratively in a dynamic environment.
- Capable of performing under pressure and meeting tight deadlines.
- Positive attitude and strong execution skills.

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