Principal Clinical Data Associate

SCiAN Services; Toronto; On-site; CAD 110,000 - 150,000; Full time

Job summary

SCiAN Services seeks a Principal Clinical Data Associate to lead the CDM program at our Head Office in Toronto. You will manage studies, interfaces with Sponsor and vendors, and ensure timely, high-quality data deliverables across the CDM lifecycle.

The role requires 8+ years in clinical data management, hands-on Medidata Rave and EDC experience, and strong communication with cross-functional teams. You will also mentor junior staff and contribute to audits and process improvements.

Qualifications

• BSc in Life Sciences preferred or Bachelor's degree with equivalent knowledge/experience.
• Minimum 8 years of experience in clinical data management.
• Experience managing CDM projects from design to database lock.
• Experience with EDC systems, including Medidata Rave.
• Knowledge 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.

Responsibilities

• 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

Skills

CDM project management

Communication skills

Interpersonal skills

Self supervision

Prioritization flexibility

CDM project oversight

Education

BSc in Life Sciences or equivalent

Tools

Medidata Rave

Lotus Notes

SAS

Job description

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