Centralized Monitor- German 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

German 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
Capability to perform Subject Level Data Review independently or in a dual role
Experience with remote monitoring visits
Skills in study-specific analytics, trend analysis, and writing analytical inferences
Ability to manage operational insights, metrics trending, triage clinical study alerts, and monitor Clinical Operation Plan (COP) compliance
Competence in developing and using study management plans, risk-based monitoring tools, and templates
Familiarity with clinical aspects including inclusion/exclusion criteria, IP, AE, Labs, EOT/EOS, endpoints, SAEs

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 of patient information
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 insights, complete study/site metrics trending, share trends, agree on action plans, review/triage/action alerts, and monitor COP compliance
Perform Subject Level Data Review independently or as dual role, including investigations on accuracy (inclusion/exclusion, IP/AE/Labs/EOT/EOS/endpoints/SAEs)
Perform remote monitoring visits for assigned sites
Perform study-specific analytics, contribute to new analytics proposals, and write analytical inferences
Provide inputs to 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/accurate documentation of site-specific tools/templates and keep sites audit-ready
Perform centralized monitoring activities, evaluate site quality/integrity per protocol/SOPs/regulations
Maintain internal systems, databases, tracking tools/reports for site-specific information
Manage triggers and prepare i-site packs for sites/countries in assigned study(ies)
Perform delegated activities

Skills

Clinical Study Management

ICH GCP

SOP Compliance

Subject Level Data Review

Remote Monitoring

Risk-Based Monitoring

Site Metrics Trending

Protocol Adherence

Data Integrity

Patient Safety

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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