Principal Clinical Data Associate

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