The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance
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Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
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Be able to support several clinical studies with minimal guidance
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Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
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Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
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Be able to perform a thoroughly detailed review of eCRF data requirements.
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Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
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Develop data edit check specifications and run data listings as required
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Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
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Develop the Data Management Plan for a clinical study.
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Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
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Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
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Perform reconciliation of header data from external data sources against the clinical database
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Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
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Assist in database upgrades/migrations including performing User Acceptance Testing
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Able to maintain study workbooks and data management files
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Perform database lock and freeze activities per company SOPs
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Participate in regular team meetings and provide input when appropriate
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Provide input into the development of data management SOPs, Work Instructions, and process documents
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Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics
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Assist with the training of new employees and/or contractors
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Collaborative relationships
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Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.
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Compliance with Parexel standards
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Complies with required training curriculum
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Completes timesheets accurately as required
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Submits expense reports as required
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Updates CV as required
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Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
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5+ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
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Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
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Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
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Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
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Possesses strong English language written and verbal communication skills.
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Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.
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