Senior Clinical Data Manager

**Remote in Canada**

**Must be eligible to work in Canada without restrictions**

**No 3rd parties**

Qualifications:

Bachelor’s 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.