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Project Manager, Clinical Study Report (CSR) Appendices - Job Opportunity at IQVIA

Remote, United States
Full-time
Mid-level
Posted: January 30, 2025
Remote
USD 85,000 - 110,000 per year based on experience level and market conditions

Benefits

Flexible remote work environment
Career development in clinical research
Global exposure across multiple countries
Professional development opportunities in pharmaceutical industry

Key Responsibilities

Strategic oversight of Clinical Study Report appendices preparation and quality management
Cross-functional leadership coordinating with clinical, regulatory, and data management teams
Critical compliance management ensuring adherence to ICH-GCP and regulatory guidelines
Quality control and stakeholder management for CSR documentation
eTMF system management and document control

Requirements

Education

Bachelor's degree in life science, pharmacy, or related health field; advanced degree preferred

Experience

3-5 years of experience in clinical research or related field

Required Skills

Clinical trial process knowledge ICH-GCP guidelines expertise CSR appendices authoring Quality control experience eTMF management MS Office Suite proficiency Project management Strong attention to detail Written and verbal communication
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on digital transformation in clinical trial documentation Growing emphasis on real-world evidence integration in clinical studies Rising demand for remote-capable clinical research professionals Heightened regulatory scrutiny in clinical documentation processes

Role Significance

Typically works within a matrix structure interfacing with 10-15 team members across different functions
Mid-level individual contributor with significant cross-functional influence

Key Projects

Multi-center clinical trial documentation Regulatory submission preparation Process improvement initiatives Quality control system implementation

Success Factors

Strong understanding of clinical research processes and regulatory requirements Exceptional attention to detail and quality control mindset Ability to manage multiple stakeholders across different time zones Excellent project management and timeline adherence

Market Demand

High demand due to increasing clinical trial volumes and regulatory requirements

Important Skills

Critical Skills

Clinical documentation expertise - essential for ensuring regulatory compliance Project management capabilities - crucial for managing multiple concurrent deliverables Quality control experience - fundamental to maintaining documentation standards Stakeholder management - vital for cross-functional coordination

Beneficial Skills

Electronic system validation knowledge Global team collaboration experience Therapeutic area expertise Process improvement capabilities

Unique Aspects

Dedicated focus on Novartis projects indicating stable long-term engagement
Home-based position offering work-life balance while maintaining global impact
Opportunity to specialize in CSR documentation while developing broader clinical research expertise

Career Growth

2-3 years in role before advancement opportunities

Potential Next Roles

Senior Clinical Documentation Manager Clinical Operations Manager Regulatory Documentation Lead Medical Writing Manager

Company Overview

IQVIA

IQVIA is a global leader in clinical research services and healthcare intelligence, formed from the merger of Quintiles and IMS Health

Industry leader in clinical research services with significant market share and global presence
Strong presence in major pharmaceutical markets with extensive remote work capabilities
Fast-paced, globally distributed teams with emphasis on collaboration and quality
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