Senior Clinical Field Specialist

JR United Kingdom; Basingstoke; On-site; GBP 40,000 - 60,000; Full time

Job summary

Une entreprise innovante est à la recherche d'un Senior Clinical Field Specialist pour superviser et mener des essais cliniques. Le candidat idéal aura une solide formation en sciences de la vie et une expertise en réglementation. Ce rôle clé impliquera de former les équipes, de garantir la conformité et de collaborer étroitement avec les acteurs de l'étude, offrant ainsi une opportunité passionnante dans un environnement dynamique.

Qualifications

• Expérience en tant que Clinical Research Associate ou similaire dans l'industrie des dispositifs médicaux.
• Bonne connaissance des exigences réglementaires (GCP, ISO14155, ICH).
• Expérience en gestion de sites et proctoring préférée.

Responsibilities

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

Skills

Organisational skills

Interpersonal skills

Communication skills

Attention to detail

Education

Bachelor’s degree in a relevant life science

Master’s degree in a relevant field

Tools

CTMS

EDC software

Job description

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Senior Clinical Field Specialist, Basingstoke

Client: The Mullings Group

Location:

Job Category: Other

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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 both diagnose Microvascular Obstruction (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 initial clinical activity for our client's innovative 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 and support the setup of site workflows to ensure consistent quality of study images and measurements.
• Maintain detailed proctoring records and documentation.
• Assist during live cases by supporting site staff.
• In agreement with CPM, authorize clinical sites to independently use the study device.
• Join occasional clinical cases to support safe and effective use of the device.

• Clinical Trial Support:
• Manage clinical trial activities in coordination with the clinical project manager from study initiation to close-out.
• Train and educate site staff on study procedures, including the use of EDC software, the electronic Investigator Site File (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 the CRO managing the overall study.

Regulatory Requirements Support:

• Assist in preparing IRB submissions and documents as needed.
• Support internal and external audits and inspections at study sites, ensuring compliance with regulations.

Data Management:

• Ensure accurate and timely data collection in eCRF, monitoring, and validation according to CIP and related documents.
• Collaborate with Data Management to resolve data discrepancies.

Qualifications:

• Bachelor’s degree in a relevant life science or healthcare field; master’s degree preferred.
• Experience as Clinical Research Associate, Clinical Specialist, or similar in the medical device or CRO industry.
• Good knowledge of GCP, ISO14155, ICH guidelines, and other regulatory standards.
• Proven experience in proctoring and site management is preferred.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills.
• Ability to work independently and in a team in a fast-paced environment.
• Proficiency in CTMS and EDC software solutions.