Key Accountabilities

• Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
• Be able to support several clinical studies with minimal guidance
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Develop data edit check specifications and run data listings as required
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
• Develop the Data Management Plan for a clinical study.
• 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
• Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries

• Perform reconciliation of header data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Assist in database upgrades/migrations including performing User Acceptance Testing
• Able to maintain study workbooks and data management files
• Perform database lock and freeze activities per company SOPs
• Participate in regular team meetings and provide input when appropriate
• Provide input into the development of data management SOPs, Work Instructions, and process documents
• Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics
• Assist with the training of new employees and/or contractors
• Collaborative relationships
• 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.
• Compliance with Parexel standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Knowledge and Experience

• At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
• 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.
• 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.