Clinical Data Manager

ICON Strategic Solutions; Canada; On-site; CAD 80,000 - 110,000; Full time

Job summary

ICON Strategic Solutions, the world's leading clinical research organization, is looking for a Clinical Data Manager. This role involves oversight on vendor management, ensuring high-quality deliverables, and maintaining compliance with industry regulations. Join us to contribute to a diverse culture that promotes talent and offers a competitive salary along with various benefits focused on well-being and work-life balance.

Benefits

Competitive salary

Health insurance

Retirement plans

Global assistance programs

Flexible benefits

Qualifications

• 4+ years in data management or drug development processes required.
• Experience managing large drug development programs preferred.
• Strong knowledge of FDA, ICH regulations.

Responsibilities

• Oversee data management functions and ensure deliverables are met.
• Collaborate with stakeholders to resolve risks.
• Manage external Data Management budgets and timelines.

Skills

Project Management

Data Management Practices

Compliance Knowledge

Education

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

Job description

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

What you will be doing:

1. Participate in study-level vendor oversight activities and represent the data management function on the Clinical Sub-team to ensure aligned expectations with the CRO and client for all data-related deliverables.
2. Serve as the first point of contact for CRO partners to ensure milestones and deliverables are met with high quality.
3. Collaborate with stakeholders and CRO partners to mitigate and resolve risks.
4. Lead and manage data collection setup, review, and database lock for studies conducted within the client, including working with other functions on EDC and other data collection tools, maintaining data cleaning plans, and overseeing data review activities.
5. Participate in preparing the function for submission readiness and represent it during inspections or audits.
6. Ensure archival and inspection readiness of all Data Management TMF documents.
7. Track study deliverables and evaluate metrics to mitigate risks related to data management milestones.
8. Manage external Data Management budgets and timelines, support continuous improvement, and prepare KPIs as needed.
9. Represent the function in external initiatives and organizations to identify industry best practices and increase visibility.
10. Contribute to continuous improvement initiatives, ensuring timely and budget-compliant deliverables.
11. Work cross-functionally to ensure data quality and on-time delivery of data management outputs.
12. Champion and adopt technological improvements and tools in data management processes.
13. Ensure compliance with training curricula, corporate, and GXP requirements.
14. Perform other duties as assigned.

What you are:

• BS/BA in health-related, life sciences, or technology fields.
• Preferred 4+ years in data management or drug development processes, with experience managing large drug development programs.
• Proven project management skills and experience with NDA/CTD preferred.
• Strong knowledge of data management practices, clinical trial documents, and industry regulations (FDA, ICH).

What ICON can offer you:

We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including leave entitlements, health insurance, retirement plans, global assistance programs, and flexible benefits.

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

ICON is committed to inclusion and providing an accessible environment for all candidates. We consider all qualified applicants equally and provide accommodations upon request.

Interested but unsure if you meet all requirements? We encourage you to apply anyway — you might be exactly what we’re looking for.