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