Clinical Document Specialist – Remote (United States)
Company: ICON plc
Job Type: Full-Time
Location: Remote – United States
Experience Required: Minimum 4+ Years in Clinical Trial Documentation / eTMF Management
About the Company
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies in accelerating drug development. The organization is recognized for operational excellence, regulatory compliance, and innovation in clinical development.
Job Overview
ICON plc is seeking a Clinical Document Specialist to support Clinical Operations and Clinical Study Teams (CST) in managing Trial Master File (TMF) documentation across the clinical trial lifecycle.
This remote opportunity is ideal for professionals with strong expertise in Veeva Vault eTMF, clinical documentation quality control, and regulatory-compliant document management within global clinical trials. The role requires a proactive individual capable of ensuring inspection readiness and documentation accuracy.
Key Responsibilities
Trial Master File (TMF) Management
Manage the lifecycle of clinical trial documentation.
File, classify, and index documents in Veeva Vault eTMF.
Ensure proper metadata tagging in alignment with the TMF Reference Model (DIA-supported).
Maintain inspection-ready TMF documentation throughout the study.
Quality Control and Compliance
Perform routine and ad hoc Quality Control (QC) reviews.
Identify documentation gaps, inconsistencies, and quality issues.
Collaborate with Functional Area Leads (FALs) to resolve findings.
Support audit and regulatory inspection readiness.
Reporting and TMF Health Monitoring
Monitor TMF health metrics and key performance indicators (KPIs).
Generate dashboards and performance reports for study teams.
Ensure alignment with Trial Master File Plans and documentation standards.
Process Improvement and Change Management
Support implementation of updated TMF processes and systems.
Develop, review, or update trial-level TMF Plans and Trial Index documents.
Provide best-practice guidance across Clinical Study Teams.
Required Qualifications and Experience
Bachelor’s Degree (preferred), ideally in Life Sciences or related field.
Minimum 4+ years of clinical trial experience, including hands-on electronic Trial Master File (eTMF) management.
Strong working knowledge of Veeva Vault eTMF.
Familiarity with the DIA TMF Reference Model.
Experience conducting Quality Control (QC) checks of clinical documentation.
Strong understanding of ICH-GCP and clinical documentation standards.
Excellent organizational and problem-solving skills.
Ability to work independently in a remote environment.
Strong attention to detail and compliance-focused mindset.
Preferred Skills
Experience supporting global, multi-site clinical trials.
Experience preparing documentation for regulatory inspections.
Knowledge of SOP-driven documentation processes.
Compensation and Benefits
ICON offers competitive compensation along with country-specific benefits focused on employee well-being and work-life balance. Benefits may include health insurance, retirement savings plans, paid leave, life assurance, and employee assistance programs.
ICON is committed to diversity, inclusion, and equal employment opportunity.
For more global clinical research and life sciences job opportunities, visit ThePharmaDaily.com.
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