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

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