Senior Clinical Field Specialist

The Mullings Group
Leeds
3 days ago
Create job alert

In recent decades treatment of heart attacks by minimally invasive percutaneous coronary intervention (PCI) has significantly improved the 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 greenfield clinical activity for our clients novel technology, overseeing and managing clinica ltrials, and taking on advanced proctroing responsibiltites.


Responsibilities:

Proctoring and Case Support Duties

  • Train assigned study staff on the correct use of the study device.
  • Supervise/support the setup of the required site workflow 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 who manages the overall clinical study.

Regulatory Requirements Support

  • Assist in the preparation 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 associated 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.

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