Key Requirements

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.

Associate Project Manager

Job Description