Position Title:Principal Clinical Data Associate Location:Head Office (Toronto, ON) Status:Full time Summary: 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/experience - Minimum 8 years of experience in clinical data management - Experienced in managing CDM projects from design to database lock - Experience with EDC systems, including Medidata Rave - Knowledge and understanding of database build, testing and documentation - Knowledge of Lotus Notes, an asset - Experience in coding AEs, medical history and concomitant medications with MedDRA and WHODrug Global - Knowledge of SAS, an asset - Excellent communication and interpersonal skills - Ability to work under minimum supervision - Flexibility in prioritization changes What 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 Sponsor - Review DB designs to ensure consistency with protocol requirements - Review custom data validation rules and checks for completeness and logic - Performs UAT testing of database design and design updates, ensures all test documentation is complete prior to DB release - Author 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 changes - Performs clinical study data review (non-medical reviews) - Reviews consistency of AE, medical history and medication coding - Ensures all processes are completed for interim and final DB locks and performs final QC checks - Provides CDM status updates to internal Project Manager and Sponsor - Manage data transfers from 3rd party vendors and to Sponsor or 3rd party vendors - Attends Sponsor team meetings - Liaises with the Biostatistics group - Participates in internal/external audits - Oversees 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