BCIRG
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Project Management
The Project Management department is a team of highly qualified individuals with experience in oncology clinical trial methodology, regulatory ICH/GCP and local laws.
The Project Management team is responsible for the logistic implementation and delivery of all CIRG/BCIRG studies, from the smaller Phase I and II studies to the large international phase III registration studies.
The department has the difficult task of converting a protocol and other controlling documents into an operational plan, and finally executing the trial from start to completion.
They communicate and coordinate across various professional groups, regions and cultures, and are highly accountable for meeting the study's timelines and staying within the outlined budget
The team is composed of:
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Global Project Coordinators (1 individual per study)
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Study Managers
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Administrative Project Coordinators
The goals of the Project Management Team are:
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To coordinate and conduct small phase I to large phase III studies, including proof of concept studies, registration or publication trials.
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To develop standards and best practices for project management methodology.
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To ensure the clinical trial process within the sponsor objective timeframe.
The Project Management Activities are to:
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Manage all administrative, logistic and scientific aspects of the study.
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Define and ensure study timelines through establish milestones.
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Interact with study sponsors, academic research organizations, investigators and their site personnel, central laboratories, national regulatory bodies and any external partners.
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Outsource, as needed activities related to project management, such as the randomization for a specific study.
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Provide monthly study reports for the study team and sponsor, monthly CRA reports and quarterly investigator newsletter.
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Review and advise on the development of the protocol, case report form and informed consent form.
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Define and develop all study related documents in accordance with CIRG and sponsor Standard Operating Procedures (SOPs) and ICH/GCP whenever applicable.
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Review, assess and select investigators and sites.
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Organize Investigator meetings.
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Supervise data collection and ensure its quality.
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Train CRAs on protocols and provide guidance on study-specific issues.
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Define the validation tools and related procedures.
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Perform data validation and coding, including patient eligibility and reconciliation of serious adverse events.
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Prepare reports for Independent Data Monitoring Committee meetings.
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Review the statistical tables and help prepare the Final Study Report.
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Review study budgets and budget follow-up.
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Negotiate contracts with investigators and external partners.
