Senior Clinical Database Designer

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

📋 Description

• Create new features and functionalities within the database design areas to enhance the efficiency of database design at the study level and improve the company's database design capabilities.

• Support Clinical Data Management in planning, directing, and overseeing the clinical database design and maintenance processes.

• Examine the protocol and related study reference materials to aid in the development of the clinical database design project timeline.

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

• Stay updated on regulatory requirements, industry trends, benchmarking, and best practices in data management and database design by engaging in reading, training, and relevant association activities.

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

• Author and review the Data Validation Specifications for assigned projects.

• Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers.

• Coordinate and supervise the UAT process for clinical databases.

• Design and assess patient Case Report Forms and database schema.

• Test data capture/entry screens through UAT.

• Participate in EDC vendor technical learning and exchange meetings, as well as other internal and external training sessions.

• Attend trial Investigators Meetings and provide user training to CRAs on utilizing EDC systems, Dataflow, and Quality Control Processes.

• Contribute to the development and maintenance of the company’s procedural documents, work instructions, checklists, and templates for all EDC systems.

• Provide input for all data management procedural documents.

• Plan, manage, control, and execute data processing tasks for assigned projects, ensuring timely and accurate completion in compliance with trial sponsors’ requirements.

• Review the Data Management Plan (DMP) for assigned projects.

• Review data, address issues, and resolve queries.

• Assist the Lead Data Manager, sponsor, or Investigative Site in resolving queries.

• Help resolve medical coding discrepancies arising from the coding of medical history, adverse events, procedures, and medicinal products.

• Collaborate with the Quality Assurance Department to support quality control audits on assigned databases.

• Validate and distribute real-time study monitoring reports to sponsors and internal team members.

• Define and oversee clinical trial data flow and quality control processes in line with corporate SOPs, Good Working Practices, and unit guidelines.

• Accurately validate electronically captured data.

• Write clear queries for missing data and data points that fail pre-defined range checks and/or logical checks.

• Engage in and contribute to Clinical Data Management initiatives.

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

⛳️ Requirements

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

• Exceptional communication skills, both orally and in writing, with personnel at all professional and administrative levels.

• Demonstrated leadership and interpersonal skills in complex team environments.

• Outstanding presentation abilities and the capacity to build strong relationships with both internal and external clients.

• Highly organized and capable of working independently while managing multiple projects/tasks effectively.

• Proven 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.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• Pension plan.

• Generous paid time off.

• Sick leave.

• Opportunity to earn a performance-based bonus.