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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.
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