Clinical Data Associate in Toronto, Ontario at Healwell AI Inc

The Clinical Data Associate, working with senior data management members, is responsible for entering clinical study data into an electronic database(s), setup databases, data cleaning/query management and documentation of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.

*This is a part-time position with an average of 20 hours per week. Must be available between Monday-Friday during core business hours, 9:00 am to 5:00 pm.

Duties and Responsibilities:

• Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
• Contributes to the development and testing of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
• Editing, processing (data entry) and entry of data into an electronic database from relevant clinical study documentation (e.g., Case Report Forms, Source Documentation)
• Resolution of database queries, as generated in real-time or following completion of all planned data entry
• QC review of entered clinical trial data to ensuring accurate and precise entry of all data
• Identifying issues and queries with study documentation and bringing this to the attention of the direct supervisor (or designate)
• Adherence to study timelines
• Performing all work in accordance with BSPI Standard Operating Procedures, relevant regulatory guidelines and study requirements
• Involved in the management of the process from DMP development to data entry, data cleaning and data transfer
• Contributes to or writes the Data Management Plan (DMP) and other data management documentation
• Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
• Performs quality control (QC) on study data as needed
• Create, review, and process data queries and updates the database
• Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
• Other duties & responsibilities as required

Qualifications: