The Research Data Specialist I will assist with the overall coordination in all aspects of data management in a clinical study at PHRI. Â They will work under the direction of a Research Project Manager I-III and (Associate) Program Manager, Research Operations, in conjunction with the study Principal Investigator to oversee the conduct of the study from conceptualization to completion. Responsibilities include: oversee the management and reporting of data;. Support integration of workflows between data management and other study processes (e.g. IP management & site management); Troubleshoot issues related to data management systems and problem solve to determine a solution; Respond to data-related questions from internal and external partners; Â Request and review reports to maintain data integrity of the study; Requesting, and testing/validation of reports; Communicate with participating clinical centres regarding data issues and query resolution;. Maintain study support tools, reports, and trackers; Maintain and manage access to the study database and systems for all study personnel;. Assist and liaise with developers and end users to support development of study-specific technology; Perform activities related to safety reporting, event adjudication, medical coding, major protocol deviations, and data transfers; and Perform activities related to major protocol deviations and data transfers.
1. Community College diploma in Business, Computer Science, or a Health-related field.
2. Experience with database management, programming, development, and use of databases is considered an asset.
3. Proficient in Microsoft Office Suite.
4. Ability to problem-solve, work independently, adapt to constant change, take initiative, self- motivate, be flexible, and multi-task.
5. Excellent communication (written and verbal) and interpersonal skills.
6. Familiarity with electronic data capture software and data authoring software such as Framemaker, iDataFax, TrialMaster, RedCAP.