Technical Skills:
• Manage delivery of projects through full EDC data management study life-cycle (with minimal guidance).
• Perform comprehensive data management tasks including data review, writing, and resolving data clarifications.
• SAE Reconciliation, Query management, Listing’s review.
• Develop and manage DM documents like Data Handling Plan (DHP), Data Review Plan (DRP), Data Management Plan for assigned trials, Manual Listings plan and validation.
• Case Report form design and review.
• Ability to perform EDC testing including test case creation, UAT.
• Work closely with the internal/external cross-functional team (CRAs, Project Managers and Statisticians) to ensure all the data related issues are resolved.
• Communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned.
• To undertake other reasonably related duties as may be assigned from time to time.
• Manage multiple projects, ensuring that timelines are met, and deliverables are of utmost quality
Additional Skills:
• Ability to successfully manage multiple tasks and timelines
• Ability to perform assigned tasks with little supervision
• Ability to liaise professionally with team members
• Strong verbal and written communication skills in English
• Demonstrated ability to learn new technologies, applications, and techniques
• Knowledge of ICH-GCP, 21CFR Part 11
Qualification:
• Bachelor's degree, or educational equivalent, in clinical, biological sciences, or related field, or nursing qualification with 4+ years of experience in core Clinical Data Management.
