Senior Clinical Database Designer

🔥 1 hour ago

🇨🇦 Canada – Remote

💵 $100k - $140k / year

⏰ Full Time

🟠 Senior

✍️ Designer

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Develop new features and functionality within database design functional areas • Assist Clinical Data Management with planning, directing, and managing clinical database design and maintenance • Review protocols and study reference materials to contribute to database design project timelines • Maintain database design timelines and promote good project management practices • Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design • Design and review case report forms (CRFs/eCRFs) and set up electronic data capture (EDC) systems for clinical trials • Author and review Data Validation Specifications • Develop and review User Acceptance Test (UAT) plans • Coordinate and oversee UAT processes • Design and review patient case report forms and database schemas • Test data capture and entry screens through UAT • Participate in EDC vendor technical learning and exchange meetings and training meetings • Participate in Investigators Meetings and provide user training to CRAs on EDC systems, Dataflow, and Quality Control Processes • Contribute to database design procedural documents, work instructions, checklists, and templates • Provide input to data management procedural documents • Plan, manage, control, and perform data processing activities for assigned projects • Review Data Management Plans • Review data and issue and resolve queries • Assist Lead Data Manager, sponsors, or investigative sites with query resolution • Assist in resolving medical coding discrepancies • Assist Quality Assurance with quality control audits • Validate and disseminate real-time study monitoring reports • Define and monitor clinical trial data flow and quality control processes • Validate electronically captured data • Write queries for missing data and data failing range or logical checks • Participate in Clinical Data Management initiatives • Develop and test SAS code for clinical trial database logical checks and study-specific monitoring reports

🎯 Requirements

• B.Sc. in Biological Sciences or Computer Science • Five years' related experience • Two to three years developing Inform and/or Medidata Rave (or similar) clinical databases • Previous Clinical Data Management experience in both paper-based and electronic data capture systems • Effective oral and written communication with personnel at all professional and administrative levels • Proven leadership and interpersonal skills in complex team situations • Excellent presentation skills and ability to build relationships with internal and external clients • Well organized, able to work independently, and able to manage multiple projects/tasks appropriately • Ability to effectively 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 and sick leave • Opportunity to earn a performance-based bonus • Remote work from a home-based office anywhere in Canada in accordance with the Work from Home policy