Full-time

IQVIA is hiring a Centralized Monitor

About the Role

IQVIA is seeking a Centralized Monitor to manage the execution of assigned clinical studies from initiation through closeout. You will ensure deliverables are completed on time and in accordance with SOPs, policies, and regulatory requirements, providing critical support across multiple projects, sites, and teams to uphold subject safety and data integrity.

What You'll Do

  • Manage assigned sites and perform Subject Level Data Review independently.
  • Perform remote monitoring visits and evaluate the quality and integrity of data from assigned sites.
  • Conduct study-specific analytics and contribute to developing new analytics proposals.
  • Manage operational insight of assigned sites/studies, completing study and site metrics trending.
  • Provide inputs to clinical study teams for continuous process improvements and issue escalation.
  • Identify value adds from centralized review and remote monitoring, providing inputs to stakeholders.
  • Support CMS leads to perform oversight on clinical deliverables for assigned projects.
  • Collaborate with project resources including CRAs, CTAs, and the Centralized Monitoring team.
  • Ensure complete and accurate documentation of all site-specific tools and templates.
  • Maintain internal systems, databases, and tracking tools with accurate information.
  • Manage triggers and prepare i-site packs for assigned sites and countries.
  • Conduct periodic reviews of site-level KRIs and historic site performance.
  • Monitor site performance and recommend timely corrective actions, reviewing their effectiveness.
  • Work in accordance with the Study Central Monitoring Plan.
  • Establish and maintain effective project and site-level communications with stakeholders.
  • Provide mentorship to Associate Central Monitors.
  • Review reports per annotations and SOPs, identify issues, and escalate to the Clinical Lead.
  • Act as a technical solution specialist (TSS) point of contact for gathering criteria and requirements.
  • Analyze requirement complexity and provide EAC hours and turnaround time estimates.
  • Review the Study Central Monitoring Plan and attend Kick-Off, weekly team, and client meetings as needed.
  • Adhere to key activities outlined in the Statement of Work per customer requirements.

What We're Looking For

  • A Bachelor’s degree in clinical, life sciences, mathematical sciences, or a related field, or a nursing qualification.
  • A minimum of 2 years of relevant work experience or an equivalent combination of education, training, and experience.
  • Fresher candidates with a Medical or Allied medical degree.
  • Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements, including ICH GCP and relevant local laws.
  • Good Clinical system expertise.
  • Strong written and verbal communication skills, including good command of the English language.
  • A results and detail-oriented approach to work delivery and output.
  • Understanding of clinical and medical data.
  • Ability to work on multiple projects and manage competing priorities.
  • Strong organizational and problem-solving skills.
  • Effective presentation skills.
  • Demonstrated ability to deliver results to appropriate quality and timeline metrics.
  • Ability to work across cultures and geographies with a high awareness of cultural differences.

Nice to Have

  • Experience in the clinical research field.
  • Good motivational, influencing, and coaching skills.
  • In-depth therapeutic and protocol knowledge.

Team & Environment

You will collaborate with project resources (CRAs, CTAs, and the Centralized Monitoring team) and report to CMS leads and the Clinical Lead.

Required Skills
Clinical MonitoringICH-GCPClinical TrialsSite ManagementRegulatory GuidelinesProtocol AdherenceRisk-Based MonitoringClinical DataSite CommunicationStudy DocumentationComplianceQuality ControlClinical Research
Invoicing holding you back?

Focus on work, not paperwork

Stop worrying about invoicing, taxes, and compliance. Glopay handles the business setup, you handle the client work. Get paid faster and look professional.

Auto-generated compliant invoices
Built-in expense management
Income reports for tax season
95% of earnings stay with you
Try Glopay free
No credit card needed
About company
IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

Visit website
Job Details
Category other
Posted 8 months ago