Senior Clinical Field Specialist

JR United Kingdom; Colchester; On-site; GBP 50,000 - 70,000; Full time

Job summary

Une entreprise innovante dans le domaine des dispositifs médicaux recherche un Senior Clinical Field Specialist à Colchester. Vous serez responsable de la formation des équipes, de la gestion des essais cliniques, et de la conformité réglementaire pour un dispositif médical de première classe visant à améliorer les résultats des patients. Ce poste requiert une expérience solide en tant que spécialiste clinique et une compréhension approfondie des exigences réglementaires.

Qualifications

• Baccalauréat en sciences de la vie ou domaine de la santé requis.
• Expérience en tant qu'Associate de recherche clinique ou spécialiste clinique.
• Connaissance des normes GCP et ISO14155.

Responsibilities

• Former le personnel de l'étude sur l'utilisation correcte du dispositif.
• Gérer les activités d'essais cliniques de l'initiation à la clôture.
• Assister à la préparation des soumissions IRB et des audits.

Skills

Organizational Skills

Communication Skills

Ability to Work Independently

Education

Bachelor’s Degree in Life Science

Master’s Degree (preferred)

Tools

CTMS

EDC Software

Job description

Social network you want to login/join with:

Senior Clinical Field Specialist, Colchester

Client: The Mullings Group

Location: Colchester, United Kingdom

Job Category: Other

-

EU work permit required: Yes

Job Views: 6

Posted: 26.06.2025

Expiry Date: 10.08.2025

Job Description:

In recent decades, treatment of heart attacks by minimally invasive percutaneous coronary intervention (PCI) has significantly improved patient outcomes. However, successful re-opening of narrow or blocked coronary arteries does not always restore blood flow to the entire heart muscle.

Our client is developing a first-in-class medical device that will diagnose MVO in real-time during PCI and serve as a treatment platform in the cath lab.

As they roll out their clinical trial across Europe, we are hiring a Senior Clinical Research Specialist to help drive clinical activity for this novel technology, oversee and manage clinical trials, and take on advanced proctoring responsibilities.

Responsibilities:

• Proctoring and Case Support Duties:
• Train assigned study staff on the correct use of the study device.
• Supervise/support the setup of site workflow to ensure consistent quality of images and measurements.
• Maintain detailed proctoring records and documentation.
• Assist during live cases by supporting site staff.
• Release clinical sites to independent use of the study device in agreement with CPM.
• Join occasional clinical cases to support safe and effective use of the device.

• Clinical Trial Support:
• Manage clinical trial activities from initiation to close-out in collaboration with the clinical project manager.
• Train and educate site staff on study protocols, use of EDC software, eISF, and regulatory requirements.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure adherence and data integrity.
• Collaborate with investigators and study staff to resolve issues and ensure timely data collection.
• Work closely with CRO managing the overall study.

Regulatory Requirements Support:

• Assist in preparing IRB submissions and documents.
• Support internal and external audits and inspections, ensuring compliance.

Data Management:

• Ensure accurate and timely data collection and validation.
• Collaborate with Data Management team to resolve discrepancies.

Qualifications:

• Bachelor’s degree in a relevant life science or healthcare field; master’s preferred.
• Experience as Clinical Research Associate, Clinical Specialist, or similar in medical device or CRO industry.
• Knowledge of GCP, ISO14155, ICH guidelines, and regulatory requirements.
• Experience in proctoring and site management preferred.
• Strong organizational and communication skills.
• Ability to work independently and in fast-paced environments.
• Proficiency in CTMS and EDC software solutions.