Senior Clinical Database Designer

This is a fully remote position, open to applicants in Canada.

📋 Description

• Create new features and functionalities within the realm of database design.

• Support Clinical Data Management by planning, directing, and overseeing clinical database design and maintenance.

• Analyze protocols and study reference materials to aid in the development of database design project timelines.

• Uphold database design timelines and encourage effective project management practices.

• Adhere to regulatory standards, industry trends, benchmarking, and best practices in both data management and database design.

• Design and evaluate case report forms (CRFs/eCRFs) and establish electronic data capture (EDC) systems for clinical trials.

• Author and critique Data Validation Specifications.

• Create and assess User Acceptance Test (UAT) plans.

• Coordinate and supervise UAT processes.

• Design and review patient case report forms and database architectures.

• Test data capture and entry interfaces during UAT.

• Engage in EDC vendor technical learning and exchange meetings as well as training sessions.

• Participate in Investigators Meetings and deliver user training to CRAs on EDC systems, Dataflow, and Quality Control Processes.

• Contribute to the development of database design procedural documents, work instructions, checklists, and templates.

• Provide insights for data management procedural documents.

• Plan, manage, control, and execute data processing tasks for assigned projects.

• Review Data Management Plans.

• Analyze data, address issues, and resolve queries.

• Assist the Lead Data Manager, sponsors, or investigative sites with query resolutions.

• Aid in the resolution of medical coding discrepancies.

• Support Quality Assurance during quality control audits.

• Validate and distribute real-time study monitoring reports.

• Define and oversee clinical trial data flow and quality control processes.

• Validate electronically captured data.

• Write queries for missing data and data that fails range or logical checks.

• Engage in Clinical Data Management initiatives.

• Develop and test SAS code for logical checks in clinical trial databases and study-specific monitoring reports.

⛳️ Requirements

• Bachelor of Science in Biological Sciences or Computer Science.

• Five years of relevant experience.

• Two to three years of experience in developing Inform and/or Medidata Rave (or similar) clinical databases.

• Prior Clinical Data Management experience in both paper-based and electronic data capture systems.

• Strong oral and written communication skills with individuals at all professional and administrative levels.

• Demonstrated leadership and interpersonal abilities in complex team environments.

• Excellent presentation skills and capacity to cultivate relationships with both internal and external clients.

• Highly organized, capable of working independently, and proficient in managing multiple projects/tasks effectively.

• Ability to efficiently organize and integrate the activities of information processing personnel.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Ability to work remotely from a home-based office anywhere in Canada in accordance with the Work from Home policy.