Clinical Data Manager - Point of Care (Ottawa)
Core
Design, validate, and maintain electronic clinical research management databases and systems to collect and archive clinical data for Point of Care diagnostic studies.
Role type
Senior Clinical Data Manager (Clinical Affairs)
Builds
Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and clinical data archives for medical diagnostics.
Domain
Healthcare diagnostics / Clinical Research
Required skills
Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Clinical Research Data Management, SAS, R, Python, Project Management, Regulatory Compliance (GCP, 21 CFR Part 11)
Preferred skills
CCDM Certification, IVD study experience, Zelta EDC experience
Technologies
Zelta EDC, SAS, SAS JMP, R, Python, SharePoint
Responsibilities
Design and maintain electronic clinical research management databases; Validate electronically captured data and resolve queries; Design case report forms and database validation checks; Train sites and study team members on data management activities; Ensure compliance with protocol and regulatory policies during clinical studies.
Seniority
Senior, hands-on IC
