Are you a talented Clinical Data Manager with EDC and clinical trial experience who thrives on accuracy, compliance, and driving research success?
Agilus by Synergie is recruiting for a Clinical Data Manager in the Medical Device in Ottawa, Ontario. This opportunity is ideal for an experienced Clinical Data Management professional who is passionate about data integrity and advancing clinical research. You will support all phases of clinical studies, from database design and validation through study closeout, ensuring high-quality, compliant data for statistical analysis.
Working closely with cross-functional teams, you will leverage your expertise in EDC systems, CTMS, and regulatory requirements to drive successful study outcomes in a collaborative, fast-paced environment.
- Design and maintain electronic data capture/management databases
- Maintenance of data management documentation and archiving clinical trial data and study documentation
- Design of case report forms and database validation checks based on an understanding of the therapeutic area of interest
- Validation of electronically captured data, querying both missing data and data points failing range checks and/or logical checks
- Design and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activities
- Training of sites and supporting study team members on data management activities at investigator meetings
- Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of junior data management staff, and follow-up of corrective actions
- Ability to travel approximately 5% (US and Canada)
- Bachelors Degree in Health, Clinical, or Biological Sciences
- Typically requires a minimum of 6 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Clinical Research Data Management or equivalent
- International Harmonized /Committee Good Clinical Practices, IHC/GCPImplementation of FDA Title 21 CFR Part 11 Compliant Data Systems Implementation of Electronic Data Capture for Clinical Studies Implementation of Clinical Trial Management Systems for Clinical Studies
Total rewards: $96000.00 - $110000.00 annually
Bi-Weekly pay including 4% vacation pay Preferred rates for benefit coverage available
Opportunity to work for an industry leader1 year contract opportunity
Soft skills:
Excellent Communications skills, both oral and written
Ability to initiate, plan and manage projects
Strong decision-making skills and ability to prioritize
Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior
Knowledge of project management tools and techniques
Broad knowledge and application of business concepts, procedures and practices
Medical Technology, Clinical Laboratory and/or In-Vitro Diagnostics experience preferred
This posting is for an active opening.
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