Clinical Data Manager

PRA International; Canada; Remote; CAD 85,000 - 120,000; Full time

Job summary

A leading clinical research organization seeks a Clinical Data Manager to ensure high-quality data deliverables in supporting key decision points and regulatory submissions. The role involves oversight of study data management activities, collaboration with external partners, and ensuring compliance with industry standards. Ideal candidates will have a BS/BA in relevant fields, at least 4 years of experience in data management, and strong project management skills, focusing on continuous improvement and collaboration in a diverse environment.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Life assurance

Flexible benefits like childcare vouchers

Qualifications

• 4+ years in data management or drug development.
• Strong knowledge of FDA and ICH regulations.
• Preferred experience with NDA/CTD.

Responsibilities

• Manage data collection setup, review, and database lock.
• Ensure quality and compliance of data throughout the clinical trials.
• Track study deliverables and evaluate metrics.

Skills

Project Management

Data Management Best Practices

Collaboration

Education

BS/BA in health-related, life sciences, or technology fields

Job description

Overview

As a Clinical Data Manager, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Participate in study-level vendor oversight activities. Represent the data management function on the Clinical Sub-team, ensuring aligned expectations between the CRO and client for all data-related deliverables, especially in support of key decision points and regulatory submissions.
• Serve as the first point of contact for CRO partners to ensure collaboration and that established milestones and deliverables are met with high quality.
• Partner with stakeholders and CRO to mitigate and resolve risks.
• Lead and manage clinical trial data collection setup, data review, and database lock for studies conducted within the client organization, including collaboration on EDC, IRT, ePRO, and eCOA setup.
• Lead creation and maintenance of data cleaning plans, including edit checks, data validation, and reconciliation plans.
• Oversee data review activities, including query management and database lock activities.
• Participate in preparation for submission readiness and represent the function during inspections or audits.
• Ensure archival and inspection readiness of all Data Management TMF documents.
• Track study deliverables, evaluate metrics, and mitigate risks associated with data management milestones.
• Manage external Data Management budgets and timelines, supporting continuous improvement.
• Represent the function in external initiatives such as SCDM, CDISC, DIA, to promote best practices and visibility.
• Contribute to continuous improvement initiatives, ensuring timely, budget-compliant deliverables.
• Work cross-functionally to ensure data quality and on-time delivery of data management outputs.
• Champion and adopt technological improvements and tools in clinical data management processes.
• Ensure compliance with training, corporate, and GXP requirements.
• Perform other duties as assigned.

Qualifications

You are:

• Educational Qualifications: BS/BA in health-related, life sciences, or technology fields.
• Experience: 4+ years in data management or drug development, with strong project management skills and experience managing large drug development programs.
• Preferred experience with NDA/CTD.
• Strong knowledge of data management best practices, technologies, and clinical trial documents.
• Solid understanding of FDA and ICH regulations and standards relevant to data capture and management.

What ICON can offer you:

Our success depends on the quality of our people. ICON offers a competitive salary and a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Flexible benefits such as childcare vouchers, gym memberships, travel passes, etc.

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON values inclusion & belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment. If you need accommodations during the application process, please contact us through the provided link.

Interested but unsure if you meet all requirements? We encourage you to apply regardless—perhaps you’re exactly what we’re looking for!