Principal Clinical Data Associate - $80 to $100K

Toronto, ON

Position Title: Principal Clinical Data Associate

Location: Head Office (Toronto, ON) - Islington Ave and 401 -  North York / Etobicoke -  TTC Islington Subway Station

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.

 

Compensation – commensurate with experience  between $80,000 and $100,000

Benefits – Health & Dental, LTD, Insurance

 

Please apply now for immediate consideration

 

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