Key Requirements

1. Science and/or medical or nursing background.

2. Minimum 5 years Clinical Research experience, oncology an advantage, with 4 years’ of project management experience in the clinical trial industry, with a proven track record in managing multi-center studies.

3. Proven ability to deliver project goals and mentor junior level employees.

4. In-depth knowledge of the Irish clinical trials environment.

5. Experience with drafting and managing Clinical Trial budgets an advantage.

6. Excellent communication skills with the ability to represent the company at an international level.

Main Function(s)

• Maintain knowledge and ensure conduct of assigned studies is in compliance with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures.

• Manage successful execution of multiple projects and lead cross-functional project teams.

Primary Responsibilities

• Manage assigned studies from concept to final study report in line with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures.

• Develop and maintain strong relationships with external stakeholders to identify new studies and manage ongoing collaborations.

• Contribute to the oversight and execution of key operational strategies and processes.

• Lead protocol development for assigned studies and liaise with the CTI Study Start-up team as required.

• Develop and execute study plans including setting project goals, leading risk assessment and management, planning resources and timelines, and study team oversight.

• Manage role and project-specific training.

• Overall responsibility for management of essential documents and Trial Master File related to assigned studies.

• Oversee the process of site visits and documentation of the visits.

• Pre-emptively identify potential issues and proactively manage resolutions and put in place, where possible, measures to minimise issues and risk for assigned studies.

• Contribute to preparation for audits and inspections, conduct, and follow-up as required both internally and at investigational sites for assigned studies.

• Assist as required with drafting and finalising budgets, roles and responsibilities prior to commencing study activities and manage throughout the lifecycle of the study.

• Take all reasonable precautions to ensure patient confidentiality is maintained.

• Contribute to departmental and cross-functional SOP development and updates as required.

• Update CTPM on the status of all clinical trial activities.

• Identify and communicate scientific misconduct according to Cancer Trials Ireland policies.

• Perform other tasks as specified by CTPM.

Clinical Project Manager (CPM)

Job Description