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
- Other duties, as assigned.

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