Associate Project Manager

Cancer Trials Ireland; Dublin; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Cancer Trials Ireland is seeking an experienced clinical trials professional to lead and oversee assigned studies in Ireland. The role requires ensuring compliance with ICH-GCP, regulatory requirements and SOPs, while coordinating sites, vendors, and study documents.

You will mentor junior staff, collaborate with Sponsors and DSSG groups, and contribute to audits, budgets, and cross-functional SOP updates. Strong communication and Irish trials knowledge are essential.

Qualifications

• Science/medical or nursing background required.
• Previous Medical or Clinical Research experience; oncology advantageous.
• Able to deliver project goals and mentor junior staff.
• In-depth knowledge of the Irish clinical trials environment.
• Experience with clinical trial budgets advantageous.
• Excellent communication skills to represent Cancer Trials Ireland nationally.

Responsibilities

• Maintain knowledge and ensure conduct of assigned studies in compliance with ICH-GCP, regulatory requirements, SOPs, study protocols and project-specific procedures.
• Lead and coordinate clinical trial activities for assigned studies.
• Develop and maintain relationships with external stakeholders/Sponsors.
• Coordinate sites, vendors, and study documents; assess country-specific documents for compliance.
• Act as primary contact for Sponsor and collaborator groups for assigned studies and DSSG groups.
• Provide project-specific training and mentor junior staff as assigned.
• Assist with audits and inspections preparation; manage essential documents and Trial Master File.
• Identify potential issues and proactively manage resolutions to minimise risk.
• Ensure compliance with Cancer Trials Ireland SOPs and other Sponsor SOPs.
• Contribute to SOP development and cross-functional collaboration.
• Organise meetings, participate in discussions with teams, and present findings.
• Assist with budgets and roles/responsibilities, and manage lifecycle of studies.
• Provide updates to COO on study status and prepare study reports.

Skills

Science/medical background

Clinical research experience

Mentoring junior staff

Strong communication

Irish clinical trials knowledge

Job description

Science and/or medical or nursing background.

Previous Medical or Clinical Research experience. Oncology an advantage.

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

In-depth knowledge of the Irish clinical trials environment.

Experience with Clinical Trial budgets an advantage.

Excellent communication skills with the ability to represent the company at a national 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.

Leadership and coordination of clinical trial activities for assigned studies.

Develop and maintain strong working relationships with external stakeholders/Sponsors.

Primary Responsibilities

Manage and coordinate assigned studies, including review, assessment and management of sites, vendors, study specific documents, development/review and assessment of country specific documents ensuring compliance with ICH-GCP and regulatory and ethical requirements.

Primary contact for Sponsor and collaborator groups for assigned studies and DSSG groups.

Manage project-specific training and mentoring of junior staff members as assigned.

Contribute to preparation for audits and inspections as required.

Overall responsibility for management of essential documents and Trial Master File where applicable.

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

Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs for all assigned studies.

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

Organise, participate in and present at meetings and discussions with other teams and team members.

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

Update COO for assigned studies on the status of all clinical trial activities.

Prepare study reports and other scientific documents as required.

Support the management of an assigned Disease Specific Sup Group (DSSG) as DSSG Coordinator, including coordinating the meetings, supporting the group’s activities, and helping to develop the trial portfolio with the DSSG Operations Lead.

Perform other tasks as specified by Line Manager.