Data Scientist at Desjardins, a financial services cooperative, developing advanced analytics, machine learning and AI models. Advising stakeholders and supporting data - driven business decisions.
About the role
- Data Manager leading clinical-trial database, validation, reconciliation, and lock activities for ClinChoice, a global full-service CRO. Hybrid permanent role in Mississauga, Ontario.
Responsibilities
- Lead data management activities for clinical trials, including database setup, study conduct, and close-out
- Ensure study deliverables meet timelines and quality standards
- Review clinical research documents, including protocols and Case Report Forms
- Create and review electronic Case Report Form specifications
- Develop Data Management Plans, Data Validation Plans, eCRF Completion Guidelines, Data Entry Guidelines, and Data Review Plans
- Develop edit rules, checks, query logic, and query messages
- Develop User Acceptance Testing Plans and test data-entry screens and edit checks
- Create and provide training to clinical teams and sites
- Perform ongoing data review and reconciliation activities
- Provide metrics and patient trackers to monitor data cleanup
- Perform database lock/unlock and freeze/unfreeze activities for statistical review, interim analysis, and final database lock
- Coordinate archiving of study databases and related documents
- Create Data Transfer Specifications and perform external vendor reconciliation
- Perform SAE reconciliation
- Maintain and improve client satisfaction through high-quality service, communication, and clinical data management
Requirements
- Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree
- At least 3 years of data management and/or related work experience in the pharmaceutical industry
- Working knowledge of clinical research, clinical trial processes, regulatory requirements, and terminology
- Strong knowledge and experience with several electronic data capture systems, such as Medidata Rave, Oracle InForm, OpenClinica, and Medrio
- Perform duties in compliance with SOPs, GCP, and ICH guidelines
- Ability to prioritize and adapt quickly in fast-paced and changing industry conditions
- Ability to lead a study or data management team independently
- Ability to drive quality and efficiency to meet timelines and milestones
- Excellent verbal and written communication skills
- Proficient in Microsoft Office, including Outlook, Word, Excel, and PowerPoint
Benefits
- Permanent employment
- Hybrid work arrangement
- Equal opportunity employer
- Inclusive, barrier-free recruitment and selection processes
- Accommodation for qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act
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