Dublin (Office or Remote)
Permanent Part-time or Full-time
October 31st 2021
Head of Clinical Operations
- Science and/or medical or nursing background.
- Minimum of 5 years’ CRA and/or Clinical Project Management experience.
·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
- 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