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Details

Clinical Project Manager


Reference:SCAWCI-444214 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Project Manager
Our Dublin based client are currently recruiting for a Clinical Project Manager to join their team on a permanent basis. As Clinical Project Manager you will be responsible for maintaining knowledge and ensuring compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures, manage assigned studies in line with SOPs and manage successful execution of one or multiple projects. The role reports directly into the Head of Operations and Clinical Programs.

Responsibilities

  • Develop and execute study plans including setting project goals, risk assessment and management, planning resources and timelines, and study team management
  • Manage performance and development of employees.
  • Manage project-specific training and mentoring
  • Contribute to preparation for audits and inspections as required
  • Evaluate and document investigator and site selection
  • Overall responsibility for management of essential documents and Trial Master File
  • Oversee the process of study initiations, monitoring and close-out
  • Develop and maintain study monitoring plan for the duration of the study lifecycle
  • Review and sign-off initiation, monitoring and close-out reports and documents
  • Participate in process of protocol development
  • Identify issues and manage the resolution process for studies under their supervision
  • Ensure compliance with all applicable SOPs
  • Input in SOP development and updates where appropriate
  • Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities
  • Manage the study budget and associated financial activities for studies under their supervision when applicable
  • Oversee Regulatory and Ethics committee submissions if applicable
  • Confirm the necessary processes are in place for study drug and other supplies for studies under their supervision when applicable
  • Take all reasonable precautions to ensure patient confidentiality is maintained
  • Organise and attend meetings as required
  • Prepare and make presentations as required
  • Update Clinical Program Lead on the status of all clinical trial activities
  • Identification and communication of scientific misconduct
  • Maintain strong relationships with external stakeholders
  • Prepare study reports as required
Requirements
  • Science and/or medical or nursing background.
  • Minimum of 5 years’ CRA and/or Clinical Project Management experience