Job description
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.
A typical day:
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)
Successful candidates will have:
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/GCP
Implementation 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 leader
1 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.