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Job Description
Seeking an experienced Clinical Project Manager to oversee the execution of multiple clinical trials, ensuring compliance with regulatory requirements and company procedures.
Reports to: Chief Operations Officer (COO)
Key Requirements:
- Science and/or medical or nursing background
- Minimum 5 years of 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 drafting and managing clinical trial budgets an advantage
- 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 Cancer Trials Ireland 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 and 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