Position Title: Principal Clinical Data AssociateLocation: Head Office (Toronto, ON)Status: Full-TimeSummary:The Principal Clinical Data Associate will manage CDM projects and resources to ensure quality, accuracy and consistency of clinical data.We are looking for someone who has:BSc. in Life Sciences preferred, or Bachelor's degree with equivalent knowledge/experienceMinimum 8 years of experience in clinical data managementExperienced in managing CDM projects from design to database lockExperience with EDC systems, including Medidata RaveKnowledge and understanding of database build, testing and documentationKnowledge of Lotus Notes, an assetExperience in coding AEs, medical history and concomitant medications with MedDRA and WHODrug GlobalKnowledge of SAS, an assetExcellent communication and interpersonal skillsAbility to work under minimum supervisionFlexibility in prioritization changesWhat you will be doing:Manage the CDM segment of studies: interface with Sponsor and 3rd party vendors, manage project CDM resources,



ensure timely completion and quality of CDM deliverables.Gather database design and configuration specifications from the SponsorReview DB designs to ensure consistency with protocol requirementsReview custom data validation rules and checks for completeness and logicPerforms UAT testing of database design and design updates, ensures all test documentation is complete prior to DB releaseAuthor and update CDM control documents, including Data Management Plan, SAE reconciliation, Laboratory / PK reconciliation plans, etc.Assess impact of protocol amendments on database design and recommend DB changesPerforms clinical study data review (non-medical reviews)Reviews consistency of AE, medical history and medication codingEnsures all processes are completed for interim and final DB locks and performs final QC checksProvides CDM status updates to internal Project Manager and SponsorManage data transfers from 3rd party vendors and to Sponsor or 3rd party vendorsAttends Sponsor team meetingsLiaises with the Biostatistics groupParticipates in internal/external auditsOversees the work of other CDAs as required. This may involve on-the-job training, and ensuring the quality of work performed.Trains and mentors junior data management staff providing timely feedback to trainees and management as appropriate

📌 Principal Clinical Data Associate (Toronto)
🏢 SCiAN Services
📍 Toronto