IQVIA · 1 day ago
Site Monitoring Lead
Durham, NC
Full-time
Onsite
Mid, Senior Level
$68K/yr - $171K/yrIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Site Monitoring Lead is responsible for authoring monitoring risk assessments and plans, maintaining sponsor oversight, and overseeing the implementation of Site Monitoring activities in clinical trials to ensure compliance and reliability of trial results.
AnalyticsHealth CareLife Science
Responsibilities
Plan trial quality and risk monitoring/ mitigation as part of the Trial Team
Deliver Risk-based Site Monitoring approach and training for the trial
Accountable for the development of the operational Site Monitoring & Oversight plans
Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates
Act as an expert and consultant on Site management and monitoring topics
Integrate patient/site level feedback to the documents ensuring design with a focus on the patient
Provide timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee)
Facilitate communication and direction with CT Managers and IQVIA CRAs
Monitor progress and oversee Site Management and Monitoring activities conducted by IQVIA partners during clinical trial conduct including adherence to ICH-GCP and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans
Pre-identification of important protocol deviations from site deviations
Continuous review, risk identification, evaluation and communication on a trial level
Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits)
Facilitate communication and training related to site monitoring in the trial
Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
Support compilation and review of the quality section for the clinical trial report for site monitoring activities
Qualification
Required
Bachelor's level degree in life sciences OR several years of equivalent professional education
Solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
Fluent in English (written and spoken)
Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team
Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action
Demonstrates active listening skills and cultural awareness
Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution
Dimensions of trial complexity include protocol, patients, sites, countries, vendors
Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams
Benefits
Incentive plans
Bonuses
Health and welfare and/or other benefits
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
Founded in 1982
10001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (294)
2023 (261)
2022 (229)
2021 (208)
2020 (180)
Funding
Current Stage
Public CompanyTotal Funding
$3.5B2025-06-02Post Ipo Debt· $2B
2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Jonathan Morris
VP & GM US Healthcare
Recent News
Sabin Vaccine Institute
2025-12-04
Company data provided by crunchbase