Clinical Data Science Lead

PRA International; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

A leading global clinical research organization is looking for a Clinical Data Science Lead. You will play a crucial role in managing data oversight and collaborating with stakeholders to ensure the success of clinical trials. This role demands strong project management skills and understanding of regulatory standards. Join us to work in a dynamic environment where your contributions significantly impact drug development processes.

Benefits

Competitive salary

Health insurance

Retirement plans

Flexible benefits

Employee Assistance Program

Life assurance

Qualifications

• Preferred 4+ years of experience in data management and drug development processes.
• Strong knowledge of data management best practices, clinical trial documents, and regulatory standards.
• Experience with NDA/CTD preferred.

Responsibilities

• Lead and manage clinical trial data collection setup, review, and database lock.
• Partner with stakeholders and CROs to mitigate and resolve risks.
• Oversee data review activities, query management, and activities for database locks.

Skills

Project management

Data management best practices

Regulatory standards knowledge

Collaboration

Education

BS/BA in a health-related, life science, or technology-related field

Tools

ecoa systems

Job description

Overview

As a Clinical Data Science Lead, 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 timely achievement of milestones and deliverables with high quality.
• Partner with stakeholders and CROs 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 other data collection tools.
• Lead creation and maintenance of data cleaning plans, including edit checks, listings, data transfer specifications, and reconciliation plans.
• Oversee data review activities, query management, and activities for interim and final database locks.
• Assist in preparing the function for submission readiness and represent the function during inspections or audits.
• Ensure archival and inspection readiness of all Data Management TMF documents.
• Monitor study deliverables and metrics to mitigate risks related to data management milestones.
• Manage external Data Management budgets and timelines, supporting continuous improvement in forecasting.
• Prepare metrics to support KPIs.
• Represent the function in external initiatives and organizations such as SCDM, CDISC, DIA, etc., to identify industry best practices and increase visibility.
• Contribute to continuous improvement initiatives, ensuring timely, budget-aligned deliverables.
• Work cross-functionally to ensure data quality and on-time delivery of data management deliverables.
• Champion and adopt technological improvements and tools for clinical data management.
• Ensure compliance with learning curricula, corporate, and GXP requirements.
• Perform other duties as assigned.

Qualifications

You are:

• BS/BA in a health-related, life science, or technology-related field.
• Preferred 4+ years of experience in data management and drug development processes, with strong project management skills.
• Experience with NDA/CTD preferred.
• Strong knowledge of data management best practices, clinical trial documents, and regulatory standards (FDA, ICH).
• Experience with ecoa systems required.

What ICON can offer you:

Our success depends on the quality of our people. We’ve built a diverse culture that rewards high performance and nurtures talent. We offer a competitive salary and benefits including various leave entitlements, health insurance, retirement plans, Employee Assistance Program, life assurance, and flexible benefits.

Visit our careers website to learn 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 let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

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