Associate Site Report Specialist
About the Role
Roles & Responsibilities
• Review Site Visit Reports (SVRs) to ensure compliance with protocol, IQVIA SOPs, ICH-GCP guidelines, and regulatory requirements
• Oversee assigned caseload of SVRs and ensure timely submission, review, and approval
• Ensure corrective and preventive action plans (CAPA) are documented and followed through to resolution
• Identify and escalate CRA/site issues, trends, and risk factors to the project team
• Provide guidance to Clinical Project Managers (CPMs) and project teams to reduce report corrections
• Track compliance to SOPs for SVR submission and approval timelines
• Participate in project meetings to address quality and performance gaps
• Coach and mentor CRAs to improve report quality and monitoring effectiveness
• Support quality improvement initiatives including quality checks, data trending, and training
• Undertake special projects aligned with functional or corporate initiatives
Qualification
• Bachelor’s Degree in Healthcare, Life Sciences, or related scientific discipline
• Equivalent combination of education and clinical research experience may be considered
Experience
• 7–8 years of clinical research experience
• Minimum 3–4 years of on-site monitoring experience
Skills
• Strong knowledge of ICH-GCP and global clinical research regulatory requirements
• Thorough understanding of clinical monitoring processes and trial systems
• Ability to manage complex study designs and multiple projects
• Strong analytical, problem-solving, and decision-making skills
• Excellent written and verbal English communication
• Effective time management and ability to manage competing priorities
• High attention to detail and quality-focused mindset
• Ability to work independently and across global, cross-cultural teams
About the Organization
IQVIA is a leading global provider of clinical research services, healthcare intelligence, and commercial insights to the life sciences industry. The organization leverages advanced analytics, technology, and scientific expertise to accelerate the development and commercialization of innovative treatments that improve patient outcomes worldwide.
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