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- Tasks: Manage clinical trial data and ensure high-quality deliverables.
- Company: Join ICON, the world's largest clinical research organisation focused on healthcare intelligence.
- Benefits: Enjoy flexible work options, health insurance, retirement plans, and a supportive work-life balance.
- Why this job: Be part of a diverse team driving innovation in clinical data management with real-world impact.
- Qualifications: Bachelor's degree in health-related fields; 4+ years in data management preferred.
- Other info: ICON values inclusivity and offers accommodations for all applicants.
The predicted salary is between 36000 - 60000 £ per year.
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:
- Participate in study-level vendor oversight activities and represent the data management function on the Clinical Sub-team to ensure aligned expectations between the CRO and client for all data-related deliverables, especially for key decision points and regulatory submissions.
- Serve as the first point of contact for CRO partners to ensure milestones and deliverables are met with high quality.
- Collaborate with stakeholders and CRO partners to mitigate and resolve risks.
- Lead and manage clinical trial data collection setup, review, and database lock for studies conducted within the client organization, including working with other functions on EDC setup and study data collection tools.
- Lead the creation and maintenance of data cleaning plans, including edit checks, data validation, and reconciliation plans.
- Oversee data review activities, query management, and activities related to database locks.
- Assist in preparing the function for submission readiness and represent it during inspections or audits.
- Ensure archival and inspection readiness of all Data Management TMF documents.
- Track study deliverables and evaluate metrics to mitigate risks related to data management milestones.
- Manage external Data Management budgets and timelines, supporting continuous improvement in forecasting.
- Contribute to industry initiatives and organizations to promote best practices and increase visibility.
- Participate in continuous improvement initiatives, ensuring timely and budget-compliant deliverables.
- Work cross-functionally to ensure data quality and timely delivery of data management outputs.
- Adopt technological improvements and tools in clinical data management processes.
- Ensure compliance with training, corporate, and GXP requirements.
- Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in health-related, life sciences, or technology fields.
- Preferred 4+ years of experience in data management or drug development, with strong project management skills.
- Experience with NDA/CTD is preferred.
- Solid knowledge of data management best practices, technologies, and clinical trial documents and processes.
- Strong understanding of FDA and ICH regulations and industry standards for data capture and management.
What ICON offers:
We prioritize diversity, high performance, and talent development. In addition to a competitive salary, ICON provides benefits focused on well-being and work-life balance, including various leave entitlements, health insurance, retirement plans, an Employee Assistance Programme, life assurance, and flexible benefits.
Visit our careers website to learn more: https://careers.iconplc.com/benefits
ICON is committed to an inclusive environment and equal opportunity employment. We welcome applications from all qualified candidates and provide accommodations upon request.
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Clinical Data Manager employer: ICON
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Data Manager
✨Tip Number 1
Familiarise yourself with the latest trends and technologies in clinical data management. Being knowledgeable about EDC systems and data validation tools can set you apart from other candidates.
✨Tip Number 2
Network with professionals in the clinical research field. Attend industry conferences or webinars to connect with potential colleagues and learn more about best practices in data management.
✨Tip Number 3
Demonstrate your project management skills by discussing relevant experiences during interviews. Highlight specific examples where you successfully managed timelines and deliverables in previous roles.
✨Tip Number 4
Stay updated on FDA and ICH regulations. Showing that you are well-versed in compliance standards will reassure employers of your capability to handle regulatory submissions effectively.
We think you need these skills to ace Clinical Data Manager
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Clinical Data Manager. Familiarise yourself with the key tasks mentioned in the job description, such as vendor oversight, data collection setup, and compliance with regulations.
Tailor Your CV: Customise your CV to highlight relevant experience in data management or clinical trials. Emphasise your project management skills and any specific knowledge of FDA and ICH regulations that aligns with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical data management. Mention specific experiences that demonstrate your ability to lead data collection efforts and manage stakeholder relationships effectively.
Highlight Continuous Improvement Initiatives: In your application, discuss any past experiences where you contributed to continuous improvement initiatives in data management. This shows your proactive approach and commitment to enhancing processes, which is valued in this role.
How to prepare for a job interview at ICON
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Clinical Data Manager. Familiarise yourself with key terms like EDC setup, data cleaning plans, and regulatory submissions. This will help you answer questions confidently and demonstrate your knowledge.
✨Showcase Your Experience
Prepare to discuss your previous experience in data management or drug development. Highlight specific projects where you successfully managed data quality and timelines, especially if they involved collaboration with CRO partners or compliance with FDA regulations.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills. Think of examples where you mitigated risks or resolved issues during a clinical trial. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Ask Insightful Questions
Prepare thoughtful questions to ask at the end of the interview. Inquire about the company's approach to continuous improvement initiatives or how they adopt new technologies in data management. This shows your genuine interest in the role and the organisation.
