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Key Requirements
- Science and/or medical or nursing background.
- Minimum 5 years Clinical Research experience, oncology an advantage, with 4 years’ experience at Associate Project Manager level.
- Proven ability to deliver project goals and mentor junior level employees.
- In-depth knowledge of the Irish clinical trials environment.
- Experience with drafting and managing Clinical Trial budgets an advantage.
- Excellent communication skills with the ability to represent the company at an international level.
- 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.
- 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 COO 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 COO.
Key Skills
Ranked by relevance
gcp
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- Posted
- May 14, 2025
- Type
- Full-time
- Level
- Mid-Senior
- Location
- Dublin
- Company
- Cancer Trials Ireland
Industries
Non-profit Organizations
Categories
Project Management
Information Technology
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