Senior Clinical Field Specialist

JR United Kingdom; Warrington; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading company is seeking a Senior Clinical Field Specialist to oversee clinical trials for an innovative medical device. This role involves managing clinical activities, training site staff, and ensuring compliance with regulations to improve patient outcomes. Ideal candidates will have a relevant degree and experience in the medical device sector.

Qualifications

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

Responsibilities

• Train study staff on device use and supervise site workflow.
• Manage clinical trial activities from initiation to close-out.
• Ensure compliance with regulatory standards and audit support.

Skills

Organizational skills

Communication

Attention to detail

Interpersonal skills

Education

Bachelor’s degree in life science or healthcare

Master’s degree preferred

Tools

CTMS

EDC software solutions

Job description

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Senior Clinical Field Specialist, Warrington, Cheshire

Client: The Mullings Group

Location: Warrington, Cheshire

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 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 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 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/support the setup of site workflows to ensure consistent quality of images and measurements.
• Maintain detailed proctoring records and documentation.
• Assist during live cases by supporting site staff.
• In agreement with CPM, authorize clinical sites for independent use of the study device.
• Join occasional clinical cases to support safe and effective device use.
• Clinical Trial Support
• Manage clinical trial activities in collaboration with the clinical project manager from study initiation to close-out.
• Train and educate site staff on study protocols, use of electronic data capture (EDC) software, Investigator Site File (ISF), and regulatory requirements.
• Conduct site qualification, initiation, monitoring, and close-out visits to ensure adherence and data integrity.
• Collaborate with investigators and site staff to resolve issues and ensure timely data collection.
• Work closely with the CRO managing the overall clinical study.

Regulatory Requirements Support:

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

Data Management:

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

Qualifications:

• Bachelor’s degree in a relevant life science or healthcare field; master’s preferred.
• Relevant experience as Clinical Research Associate, Clinical Specialist, or similar in medical device or CRO industry.
• Good knowledge of GCP, ISO14155, ICH guidelines, and other regulatory standards.
• Experience in proctoring and site management 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.