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Senior Clinical Field Specialist, Crawley, West Sussex
Client: The Mullings Group
Location: Crawley, West Sussex, 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 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 to help drive clinical activity for their 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 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.
- 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 study device.
- Clinical Trial Support
- Manage clinical trial activities from study initiation to close-out, in collaboration with the clinical project manager (CPM).
- Train and educate site staff on study CIP, use of the study EDC software, 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 site 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.
- Assist in 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 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.
- Knowledge of GCP, ISO14155, ICH guidelines, and other regulatory requirements.
- Experience in proctoring and site management preferred.
- Strong organizational skills and attention to detail.
- Good communication and interpersonal skills.
- Ability to work independently and in a team in a fast-paced environment.
- Proficiency in CTMS and EDC software solutions.