Associate Site Report Specialist
Location: Thane, India (Home-Based)
Job Type: Full-Time
Reference ID: R1528212
Company: IQVIA
The Associate Site Report Specialist plays a critical role in ensuring the quality, compliance, and regulatory integrity of clinical trial documentation. This position is responsible for the comprehensive review of Site Visit Reports (SVRs) to support subject safety, data accuracy, and adherence to global regulatory standards including ICH-GCP guidelines.
This opportunity is ideal for experienced clinical research professionals with strong monitoring expertise and in-depth knowledge of regulatory frameworks who are seeking to contribute to high-quality clinical trial execution within a globally recognized organization.
Key Responsibilities
Review and manage a caseload of Site Visit Reports (SVRs) to ensure compliance with study protocols, timelines, applicable SOPs, and Good Clinical Practice (GCP) guidelines.
Ensure corrective and preventive action plans are properly documented and followed through to resolution to maintain high-quality reporting standards.
Identify, escalate, and track CRA and site-related issues, emerging trends, and risk factors to relevant stakeholders in a timely manner.
Provide guidance to Clinical Project Managers (CPMs) during study start-up and throughout the trial lifecycle to minimize report corrections and enhance quality.
Monitor compliance with SOP requirements for SVR submission and approval processes.
Participate in cross-functional meetings to discuss report quality issues and contribute to trend analysis through the Issue Escalation Log.
Coach and mentor Clinical Research Associates (CRAs) to improve documentation quality and reduce reporting discrepancies.
Support continuous quality improvement initiatives including data trending, quality checks, mentoring junior staff, and participating in special projects.
Required Qualifications
Bachelor’s Degree in Healthcare, Life Sciences, or a related scientific discipline (or equivalent education and experience).
7–8 years of clinical research experience.
Minimum 3–4 years of on-site clinical monitoring experience.
Strong knowledge of ICH guidelines, Good Clinical Practice (GCP), and global regulatory requirements.
In-depth understanding of clinical monitoring processes, clinical trial systems, and applications.
Experience managing complex study designs and multiple concurrent studies.
Excellent written and verbal communication skills in English.
Strong analytical, organizational, and time management abilities.
Ability to work independently and collaboratively across diverse cultures and geographies.
High attention to detail and strong quality orientation.
About IQVIA
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial intelligence for the life sciences industry. The organization accelerates the development and commercialization of innovative medical treatments by delivering data-driven insights that improve patient outcomes worldwide.
IQVIA maintains a strict commitment to integrity and transparency in its recruitment process. All submitted credentials and application details must be accurate and complete. Any misrepresentation may result in disqualification or termination in accordance with applicable laws.
Uttar Pradesh :
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Kyiv |Lima Region :
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