Principal Clinical Data Associate - $80 to $100K
Candido Consulting Group Inc.
Mississauga, ON, Canada
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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