Clinical Data Science Lead

PRA Health Sciences; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading clinical research organization is seeking a Clinical Data Science Lead to manage data activities for clinical studies. In this role, you will ensure high-quality deliverables and collaboration among stakeholders. Responsibilities include overseeing vendor activities, leading data management tasks, and ensuring compliance with regulatory standards. Candidates should have a strong background in data management with at least 4 years of relevant experience and a BS/BA in health, life sciences, or technology.

Benefits

Various annual leave entitlements

Health insurance options

Retirement plans

Global Employee Assistance Programme

Life assurance

Flexible benefits like childcare vouchers, gym discounts

Qualifications

• At least 4 years in data management or drug development.
• Knowledge of FDA and ICH regulations.
• Proven skills managing large drug development data activities.

Responsibilities

• Oversee data management activities within clinical studies.
• Lead creation and maintenance of study data cleaning plans.
• Serve as the first point of contact for CRO partners.

Skills

Project Management

Data Management Best Practices

Cross-Functional Collaboration

Education

BS/BA in Health, Life Sciences, or Technology

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:

1. 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.
2. Serve as the first point of contact for CRO partners to ensure milestones and deliverables are met with high quality.
3. Partner with stakeholders and CROs to mitigate and resolve risks.
4. Lead data management activities within studies conducted by the client, including study data collection setup, data review, and database lock, by working with other functions to set up EDC, IRT, ePRO, and eCOA systems.
5. Lead creation and maintenance of study data cleaning plans, including edit checks, data validation, and reconciliation plans.
6. Oversee data review activities, query management, and activities for database locks.
7. Assist in preparing for submission readiness and represent the function during inspections or audits.
8. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
9. Track study deliverables and metrics to mitigate risks for data management milestones.
10. Manage external Data Management budgets and timelines, supporting continuous improvement.
11. Prepare metrics to support KPIs.
12. Represent the function in external initiatives like SCDM, CDISC, DIA, to adopt industry best practices and enhance visibility.
13. Contribute to continuous improvement initiatives, ensuring timely, budget-compliant deliverables.
14. Work cross-functionally to ensure data quality and on-time delivery of data management outputs.
15. Champion and adopt technological improvements and tools in clinical data management.
16. Ensure compliance with learning curricula, corporate, and GXP requirements.
17. Perform other duties as assigned.

Qualifications

You are:

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

Experience:

• At least 4 years of experience in data management or drug development, with cross-functional interface knowledge.
• Proven project management skills managing data activities for large drug development programs.
• NDA/CTD experience preferred.
• Strong knowledge of data management best practices, clinical trial documents, FDA, and ICH regulations.
• Experience with ecoa systems required.

What ICON can offer you:

Our success depends on our people. We prioritize diversity, high performance, and talent development. Benefits include:

• Various annual leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme
• Life assurance
• Flexible benefits like childcare vouchers, gym discounts, etc.

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

ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment. If accommodations are needed, please inform us 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 need!