Senior Clinical Field Specialist

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

Job summary

A leading company in the healthcare sector is looking for a Senior Clinical Field Specialist to oversee clinical trials and support innovative technology in the cath lab. The ideal candidate will possess strong organizational and communication skills, alongside relevant educational qualifications in life sciences, and experience in the medical device industry. This role offers an opportunity to be at the forefront of medical technology development in a dynamic environment.

Qualifications

• Experience as Clinical Research Associate or Clinical Specialist in medical device or CRO industry.
• Good knowledge of GCP, ISO14155, ICH guidelines.
• Proven experience in proctoring and site management preferred.

Responsibilities

• Oversee and manage clinical trials, providing proctoring and case support.
• Train site staff on device usage and regulatory requirements.
• Ensure accurate and timely data collection throughout trials.

Skills

Organizational skills

Attention to detail

Communication skills

Interpersonal skills

Education

Bachelor’s degree in life science or healthcare field

Master’s degree preferred

Tools

CTMS

EDC software solutions

Job description

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Senior Clinical Field Specialist, Bedford

Client: The Mullings Group

Location: Bedford, 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 outcomes for patients. However, successful re-opening of the 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 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 who will help drive clinical activity for our client's innovative technology, overseeing and managing clinical trials, and taking 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 workflows to ensure study images and measurements are collected and of consistent quality.
• Maintain detailed proctoring records and documentation.
• Assist during live cases by supporting site staff.
• In agreement with CPM, release clinical sites to independent use of the study device.
• Join occasional clinical cases to support safe and effective use of the study device.

• Clinical Trial Support
• Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation to close-out.
• 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.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure CIP adherence and data integrity.
• Collaborate with investigators and study site staff to resolve issues and ensure timely and accurate data collection.
• Work in close collaboration with CRO managing the overall clinical study.

Regulatory Requirements Support:

• Assist in the preparation of IRB submissions and documents, as needed.
• Assist in internal and external audits and inspections at study sites, ensuring compliance with regulatory requirements.

Data Management:

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

Qualifications:

• Bachelor’s degree in a relevant life science or healthcare field; master’s degree preferred.
• Relevant 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 relevant regulatory requirements.
• Proven experience in proctoring and site management preferred.
• Strong organizational skills and attention to detail.
• Good communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in using CTMS and EDC software solutions.