Clinical Project Manager

Location
Dublin (Office or Remote)
Contract Type
Permanent Part-time or Full-time
Closing Date
October 31st 2021

Reports to:
Head of Clinical Operations

Key Requirements

  • Science and/or medical or nursing background.
  • Minimum of 5 years’ CRA and/or Clinical Project Management experience.

Main Function(s)

·Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures. ·Manage assigned studies in line with CANCER TRIALS IRELAND SOP

Primary 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 CANCER TRIALS IRELAND and/or other Sponsor SOPs if applicable for all studies under their supervision.
  • 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 CPL 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.
  • Perform other tasks as specified by Head of Operations and Clinical Programs