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Senior Clinical Trial Coordinator/Project Manager

Senior Clinical Trial Coordinator/Project Manager

Job description

Senior Clinical Trial Coordinator/Project Manager

About Your New Employer

Since 1845, our client has been sharing the highest quality teaching and research with Ireland and the World.

About Your New Job   

  • Lead on the overall regulatory strategy for the study in line with MDR 2017/745, ISO14155 and GDPR requirements with input from local regulatory experts across Europe for the trial.
  • Project lead for one of Corrib’s main full service multi-site multi country trial and lead the project research team, acting as the driver of the research project and outputs.
  • Able to manage and oversee research projects and to take responsibility for their overall success
  • Undertake periodic landscape review for legislative requirements and implement processes to incorporate changes into existing systems or introduce new processes to ensure regulatory compliance.
  • Implement systems to ensure compliance with all applicable regulations and guidelines, ARO coordination level SOPs and/or ARO site SOPs as required.
  • Undertake clinical data compilation and literature reviews for the research area and participate in dissemination of same at international meetings.

 What Skills You Need

  • Primary/Master’s Degree level qualification in a clinical or life sciences related subject.
  • Minimum of 4- 6 years’ post qualification experience gained working in clinical research or a closely related field e.g. Pharma or Medical Device sector.
  • Have an established reputation for the quality of their research work.
  • Independent researcher with experience leading significant research project(s)/teams
  • Previous experience gained in a medical device clinical trial co-ordination unit (Commercial CRO or ARO) organisation delivering coordination services for device trials is required for this role with experience gained in any or all of the following: (a) clinical trial co-ordination/project or site management (b) clinical trial monitoring role (c) clinical trial data management role or (d) safety management.
  • Experience in operational delivery of multisite studies.
  • Experience working within a Quality Management adhering to QC and QA control systems and risk management processes.
  • Leadership and mentoring skills.
  • Excellent verbal and written communication/presentation skills.

 What’s Next

  • Apply now by clicking the “Apply Now" button or call me, Nicola Walsh on +353 91 455304 Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.

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