Job Title

Remote in Canada Must be eligible to work in Canada without restrictions No 3rd parties Qualifications: Bachelors Degree 5 years of relevant experience (with recent CRO) Job Duties Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions. Primpary contact person for day to day data management activities, and for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues. Responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting. Assist with study-level resource planning and management, including the review of team members timesheet reports. Assist in performing client relationship management activities. Participate in project bid defense meeting when required. Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel. Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel. Assist in generation of project Work Orders and Amendments. Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors). Participate in project kick off meeting, investigators meeting, and team meetings Provide support to client audits and regulatory inspections. Follow up on audit findings. Create and maintain clinical trial Data Management Study Binders. Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms. Design and review Clinical Trial Source Document templates and completion instructions when required. Develop and maintain data validation specifications. Participate in EDC UAT Manage the process of database modifications (after go-live) due to protocol amendments or study needs. Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP. Perform Third Party non-CRF data management activities. Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries. SAE reconciliation. Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products. Cooperate and assist the Quality Assurance Department with quality control audits on assigned databases. Perform database soft-lock and hard lock activities. Final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.