Global Study Management Associate
New
B
BeOneClinical research
Remote (US)Full-TimeMiddle
Salary$72,800.00 - $97,800.00 annually
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Job Details
- Experience
- 1 or more years of experience in clinical research within Biotech, Pharma or CRO industry
- Required Skills
- SharePointMicrosoft ExcelMS OfficePowerPoint
Requirements
- Hold a bachelor’s or higher degree in a scientific or healthcare discipline; a higher degree is preferred.
- Have at least 1 year of clinical research experience in the biotech, pharma, or CRO industry.
- Have knowledge of clinical operations methodologies and operational aspects of clinical study processes.
- Be proficient in the MS Office Suite, including Excel and PowerPoint.
- Understand clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines.
- Be able to travel on a limited basis if required.
Responsibilities
- Support the Global Clinical Study Manager in delivering global clinical studies to quality, timeline, and budget expectations.
- Organize logistics for cross-functional Clinical Study Team meetings and collaborate with global and regional stakeholders.
- Create and maintain study-level SharePoint resources, distribution lists, and information in eTMF, CTMS, and other study systems.
- Manage study system access and support user account management throughout the study lifecycle.
- Support study plan development and organize investigator meetings under the Global Clinical Study Manager’s supervision.
- Track study deliverables, including screening, enrollment, biological samples, images, data flow, and protocol deviations.
- Prepare management metrics, study newsletters, and other study-related correspondence.
- Support study-level TMF creation and maintenance, including document review and quality control.
- Support study drug forecasts, data cleaning, Clinical Study Report planning, and follow-up of outstanding information.
- Support operational risk identification, vendor setup, study budget activities, purchase order setup, and invoice tracking.
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