Centralized Monitor- French Speaker at IQVIA

Sofia, Sofia City Province, Bulgaria

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

French Speaker
Ability to manage clinical studies from initiation through closeout
Knowledge of standard operating procedures (SOPs), policies, Good Clinical Practice (GCP), ICH GCP guidelines, and regulatory requirements
Proficiency in reviewing structured clinical data output with access to medical charts
Skills in subject level data review, including inclusion/exclusion criteria, IP, AE, Labs, EOT/EOS, endpoints, SAEs
Capability to perform remote monitoring visits
Experience with study-specific analytics, trend analysis, metrics trending, and clinical study alerts
Ability to develop and use study management plans, risk-based monitoring tools/templates
Competence in writing analytical inferences and contributing to new analytics proposals
Familiarity with clinical operation plan (COP) compliance and monitoring strategies

Responsibilities

Manage the execution of assigned clinical study(ies) from initiation to closeout, ensuring on-time deliverables per SOPs, policies, and practices
Provide project-related support across multiple projects, sites, and teams
Review structured clinical data output and ensure adherence to protocol, completeness, and readiness for next-level review
Facilitate review of Site Visit Reports and assure consistent quality standards
Ensure subject safety, data integrity, issue escalation, and timely feedback per IQVIA SOPs, ICH GCP, protocol, and regulations
Develop and use study management plans, risk-based monitoring tools, and support monitoring strategy development
Manage operational insight of assigned projects/sites, including metrics trending, trend analysis, action plans, alert triage, and COP compliance
Perform Subject Level Data Review independently or in dual role, including investigations with clinical sites
Perform remote monitoring visits for assigned sites
Perform study-specific analytics and contribute to new analytics proposals
Provide inputs to clinical study teams for process improvements, issue escalation, and workload projections
Identify value-adds from centralized review/remote monitoring and provide inputs to stakeholders
Support CMS leads in oversight of clinical deliverables per protocol, SOPs, regulations, and project plans
Collaborate with project resources (CRAs/CTAs/Centralized Monitoring team)
Ensure complete and accurate documentation of site-specific tools/templates and keep sites audit-ready
Perform centralized monitoring activities and evaluate site quality/integrity
Maintain internal systems, databases, tracking tools/reports for site-specific information
Manage triggers and prepare i-site packs for sites/countries
Perform delegated activities

Skills

Key technologies and capabilities for this role

Clinical Study ManagementSOP ComplianceICH GCPSubject Level Data ReviewRemote MonitoringRisk-Based MonitoringSite Visit ReportsData IntegrityTrend AnalysisProject ManagementFrench

Questions & Answers

Common questions about this position

What is the employment type for this Centralized Monitor role?

The position is full-time.

Is this Centralized Monitor position remote or office-based?

This information is not specified in the job description.

What are the key skills required for the Centralized Monitor - French Speaker role?

Key skills include French language proficiency, performing subject level data review, remote monitoring visits, study-specific analytics, and metrics trending analysis. Experience ensuring compliance with SOPs, ICH GCP guidelines, and regulatory requirements is essential.

What is the company culture like at IQVIA for this role?

This information is not specified in the job description.

What makes a strong candidate for this Centralized Monitor position?

Strong candidates have experience managing clinical studies from initiation to closeout, proficiency in French, skills in subject level data review, remote monitoring, analytics, and ensuring compliance with SOPs, ICH GCP, and regulatory standards.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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