Clinical Data Manager

PRA Health Sciences; United States; Remote; USD 95,000 - 140,000; Full time

Job summary

Join a leading clinical research organization as a Clinical Data Manager, where you will oversee data management functions, ensure quality deliverables, and collaborate with stakeholders. This role offers a chance to work in a dynamic environment while contributing to the success of clinical trials, with an emphasis on risk mitigation and compliance.

Benefits

Competitive salary

Health insurance

Retirement plans

Various leave entitlements

Work-life balance focus

Inclusion and diversity commitment

Qualifications

• 4+ years in data management and/or drug development processes preferred.
• Experience with NDA/CTD preferred.
• Strong knowledge of clinical trial documents.

Responsibilities

• Oversee data management function and ensure quality deliverables.
• Lead data collection setup, data review, and database locks.
• Manage external Data Management budgets and timelines.

Skills

Data management best practices

Regulatory compliance

Collaboration

Risk management

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

• Participate in study-level vendor oversight activities, representing the data management function on the Clinical Sub-team to ensure 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 milestones and deliverables are met with high quality.
• Collaborate with stakeholders and CRO partners to mitigate and resolve risks.
• For studies where data management activities are conducted within the client, lead and manage clinical trial data collection setup, data review, and database lock, including working with other functions to set up EDC and other data collection tools like IRT, ePRO, and eCOA.
• Lead the creation and maintenance of study data cleaning plans, including edit checks, listing review checks, data integration and transfer specifications, external data reconciliation plans, coding guidelines, SAE reconciliation, and database lock plans.
• Manage data review activities, including query management, and oversee activities for interim and final database locks.
• Participate in preparing the function for submission readiness and represent the function during inspections or audits.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Track study deliverables and evaluate study 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 and represent the function in external initiatives such as SCDM, CDISC, DIA, etc.
• Contribute to continuous improvement initiatives, ensuring timely and budget-compliant deliverables.
• Work cross-functionally to ensure data quality and timely delivery of all data management outputs.
• Champion and adopt new technology tools for clinical data management processes.
• Ensure compliance with learning curricula, corporate, and GXP requirements.
• Perform other duties as assigned.

Qualifications

• BS/BA in health-related, life sciences, or technology fields.
• Preferred 4+ years in data management and/or drug development processes, with experience managing large programs and cross-functional interfaces.
• Experience with NDA/CTD preferred.
• Strong knowledge of data management best practices, technologies, and clinical trial documents.
• Excellent understanding of FDA and ICH regulations and industry standards.

What ICON can offer you:

Our success depends on our people. We offer a competitive salary, benefits focused on well-being and work-life balance, including various leave entitlements, health insurance, retirement plans, and more. We are committed to inclusion and diversity, providing an accessible environment for all candidates.