Key Facts

Remote From:

Full time

English

Hard Skills

Database Triggers Remote Administration Cross-Functional Collaboration Data Mining Industry Trend Analysis Adverse Event Monitoring Project Status Reports Clinical Data Analysis Regulatory Compliance Escalation Procedures +9 more

Other Skills

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Microsoft Excel
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Quality Assurance
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Accountability
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Communication
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Teamwork
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Detail Oriented
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Problem Solving

Roles & Responsibilities

Bachelor's degree in life sciences or related field, or nursing qualification; or near to obtain the degree - Mandatory
+2 years of monitoring experience (on site or remote) - Mandatory
Advanced level of Excel
Advanced level of English - Mandatory

Requirements:

Perform centralized monitoring activities on assigned projects, evaluating study quality and data integrity per the protocol, SOPs, regulations and guidelines; ensure accurate completion and maintenance of internal systems, databases, and tracking tools/reports for project-specific information.
Manage triggers and prepare i-site packs for sites and countries for the assigned study(ies); escalate quality issues to the Centralized Monitoring Lead/Sr. Central Monitor as needed.
Participate in study team meetings and interact with cross-functional staff to verify information, triage new data issues or prior action items; may perform Subject Level Data Review requiring further investigation with the clinical site.
Engage with sites/CRAs and follow up on study milestones from project start to close out; may act as backup for delegated tasks per Central Monitor Expert/Centralized Monitoring Lead.

IQVIA

Health Care

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

Company type: Large

Industry: Health Care

Founded: 2018

Company size: 10001

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Job description

Job Overview

A Central Monitor is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. Provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.

Essential Functions:

Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs, respective regulations and guideline.
Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
May assist in developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
Participate on study team meetings and interact with cross functional staff to verify information and/or triage new data issues or prior identified action items.
Escalate quality issues pertaining to site to respective Centralized Monitoring Lead/ Sr. Central Monitor.
May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.
Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.
May act as backup/ perform the activities as per the task list delegated by Central Monitor Expert/Centralized Monitoring Lead.

Qualifications:

Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtain the degree - Mandatory.
+2 years of monitoring experience (on site or remote) - Mandatory.
Advanced level of Excel.
We are looking for someone with advanced level of English - Mandatory. You could support sites either in Latin America or North America.

This is a home based position.

#LI-Remote #LI-NRJ

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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