Centralized Monitor- Dutch 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, PharmaceuticalIndustries

Requirements

Dutch 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 performing Subject Level Data Review independently or in dual role
Capability to perform remote monitoring visits
Expertise in analyzing inclusion/exclusion criteria, IP, AE, Labs, EOT/EOS, endpoints, SAEs
Ability to perform study-specific analytics and develop new analytics proposals
Skills in metrics trending, trend analysis, triage/action of alerts, and monitoring COP compliance
Experience with study management plans, risk-based monitoring tools/templates
Ability to provide inputs for process improvements, issue escalation, workload projections
Proficiency in documentation, internal systems, databases, tracking tools/reports
Capability to manage triggers and prepare i-site packs

Responsibilities

Manage execution of assigned clinical studies from initiation to closeout, ensuring on-time deliverables per SOPs, policies, and practices
Provide project support across multiple projects, sites, and teams
Review structured clinical data output with medical charts for protocol adherence, completeness, and readiness
Facilitate review of Site Visit Reports and ensure 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/templates, and study-specific plans
Support project management in developing monitoring strategy, including triggers/thresholds
Manage operational insight of projects/sites, complete metrics trending, trend analysis, action plans, alert triage, COP compliance
Perform Subject Level Data Review independently or in dual role for assigned sites
Conduct remote monitoring visits for assigned sites
Investigate data requiring site clarification for accuracy
Perform study-specific analytics and contribute to new analytics proposals with analytical inferences
Provide inputs to teams for process improvements, escalations, projections
Identify value-adds from centralized review/remote monitoring and inform stakeholders
Support CMS leads in oversight of clinical deliverables per protocol, SOPs, regulations, COP
Collaborate with project resources (CRAs/CTAs/Centralized Monitoring team)
Ensure complete/accurate documentation of site-specific tools/templates and audit readiness
Perform centralized monitoring activities, evaluating site quality/integrity
Maintain internal systems, databases, tracking tools/reports for site information
Manage triggers and prepare i-site packs for sites/countries
Perform delegated activities

Skills

Dutch Language

Clinical Study Management

GCP

ICH-GCP

SOP Compliance

Remote Monitoring

Risk-Based Monitoring

Data Review

Protocol Adherence

Metrics Trending

Site Visit Reports

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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