Clinical Specialist

Job Description:

The position includes a diverse set of duties. In addition to your critical role in overseeing and managing clinical trials, you will take on advanced proctoring responsibilities.

As a Clinical Specialist, you will train study site staff on the correct use of the study device and provide input during live cath lab procedures. Periodic technical case support at investigator sites is also expected to ensure safe and effective use of the medical technology, meeting study protocols.

If you are a proactive, collaborative, service-minded, and detail-oriented individual with a passion for advancing medical research and a proven track record in medical device clinical trials, we encourage you to apply.

Key Responsibilities

Proctoring and Case Support Duties:

1. Train assigned study staff on the correct use of the study device.
2. Supervise/support the setup of the required site workflow to ensure ideal basis for enrolment and that study images and measurements are collected and of consistent quality.
3. Maintain detailed proctoring records and documentation.
4. Assist remotely or on-site during live cases by supporting site staff in the correct use of the study device and the CIP.
5. In agreement with CPM, release clinical sites to independent use of the study device.

Clinical Trial Support:

1. Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation, enrolment to study close-out.
2. Train and educate site staff on study CIP, the correct use of the study EDC software, the electronic Investigator Site File (eISF), and regulatory requirements.
3. Conduct site qualification, initiation, monitoring, and close-out visits to ensure CIP adherence and data integrity.
4. Collaborate with investigators and study site staff to resolve issues and ensure timely and accurate data collection.
5. Work in close collaboration with the study-assigned CRO (if applicable).

Desired Qualifications

1. Bachelor's degree in a relevant life science or healthcare field, master's degree preferred.
2. Relevant experience as Clinical Field Trial Specialist, Field Technical Specialist or similar.
3. Proven experience in proctoring and site management preferred.
4. Native Italian, Fluent French and/or Spanish (both written and spoken).
5. Fluent English (both written and spoken).
6. Strong organizational skills and attention to detail.
7. Good communication and interpersonal skills.
8. Ability to work independently and collaboratively in a fast-paced environment.
9. Proficiency in additional languages (Italian, German, and/or Spanish) are preferred.
10. Willingness to travel up to 60-80% within EU.