Clinical Data Manager

Agilus Consulting Group; Ottawa; On-site; CAD 96,000 - 110,000; Full time

Job summary

Agilus Consulting Group in Ottawa, Ontario is seeking a Clinical Data Manager with strong EDC and CTMS experience to support all phases of clinical studies, ensuring data integrity and regulatory compliance.

You will design and validate databases, create case report forms, perform data validations, and collaborate with cross-functional teams to drive timely study closeouts. Travel approx. 5% to US/Canada may be required.

Qualifications

• Experience with EDC and CTMS in clinical trials.
• Knowledge of ICH/GCP and FDA Title 21 CFR Part 11 standards.
• Ability to design and validate databases for trials.

Responsibilities

• Design and maintain electronic data capture/management databases.
• Validate data with queries and range/logical checks.
• Create source documents and reports for monitors.
• Train sites and study teams on data management activities.
• Ensure protocol compliance and regulatory guidance across studies.
• Travel approximately 5% (US and Canada).

Skills

EDC systems

CTMS

Regulatory requirements

Data integrity

Education

Bachelor's degree in Health, Clinical, or Biological Sciences

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 ManagementSystems (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 SystemsImplementation of Electronic Data Capture for Clinical StudiesImplementation of Clinical Trial Management Systems for Clinical Studies

Total rewards: $96000.00 - $110000.00 annuallyBi-Weekly pay including 4% vacation payPreferred rates for benefit coverage availableOpportunity to work for an industry leader1 year contract opportunity

Soft skills:Excellent Communications skills, both oral and writtenAbility to initiate, plan and manage projectsStrong decision-making skills and ability to prioritizeAbility to form and develop interpersonal, professional relationships; display socially and professionally appropriate behaviorKnowledge of project management tools and techniquesBroad knowledge and application of business concepts, procedures and practicesMedical Technology, Clinical Laboratory and/or In-Vitro Diagnostics experience preferred

This posting is for an active opening.