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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Operations Lead


Reference:SCATGB-222700 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Operations Lead
Our Dublin based client are currently recruiting for a Clinical Operations Lead to join their team on a permanent basis. As Clinical Operations Lead you will be responsible for managing staff, leading the training and the career development pathway of new clinical research staff including Clinical Trials Assistants and Clinical Research Associates, maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures) & manage the optimal resourcing of clinical research staff and the planning and forecasting of clinical resource requirements.


Responsibilities

  • Develop and execute training and development plans for assigned clinical research staff
  • Manage performance reviews of assigned clinical research staff
  • Conduct in-house and on-site training of assigned clinical research staff
  • Lead the CRA forum
  • Manage resource planning of assigned clinical research staff
  • Collaborate with project teams, financeand the Head of Operations & Clinical Programs on resource requirements for specific projects according to study-specific budgets and forecasting resource planning
  • Collaborate with Human Resources and external agencies in the recruitment of new clinical research staff
  • Oversee mentoring arrangements of assigned clinical research staff
  • Identify and escalate HR issues and manage the resolution process as required
  • Ensure compliance with all company policies & SOPs and Sponsor SOPs
  • Input in policy and SOP development and updates where appropriate
  • Take all reasonable precautions to ensure patient confidentiality is maintained
  • Organise and attend meetings as required
  • Prepare and make presentations as required
  • Identification and communication of scientific misconduct
  • Maintain strong relationships with external stakeholders
Requirements
  • Science and/or medical or nursing background
  • Comprehensive knowledge of Clinical Research quality standards and Irish/European/ International regulatory requirements
  • Experience in line management and team resource planning required including experience as a Senior or Lead CRA
  • Oncology background/experience
  • Understanding the commercial environment