Clinical Monitoring Analyst (Cluepoints) - Remote at IQVIA

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

At least 3 years relevant experience in pharmaceutical research and development or related field, preferably in centralized monitoring, data management, and/or biostatistics
2-3 years SAS experience preferred, including macro language
Prior experience in a Data Management related field
Experience with relational databases, preferably Clinical Data Management and EDC Systems
Ability to work autonomously and engage with relevant stakeholders
Ability to understand basic statistical analysis concepts and interpret their outcomes
Ability to maintain confidentiality of data and information
Ability to work with limited close supervision
Demonstrated communication, interpersonal, organizational, and problem-solving skills
High levels of initiative, drive, and commitment
Experience communicating with all levels of personnel and participating in collaborative work teams (locally and globally)
Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
Excellent command, both verbal and written, of English
Strong communication and organization skills
Experience with SAS programming

Responsibilities

Support the Centralized Monitoring Lead (CML) in developing the fit-for-purpose CM strategy by contributing to identification of relevant CM elements (QTL, KRIs, data visualizations, Data Quality Assessments)
Setup/program QTL, KRI, and Data Quality Assessments according to the study CMP
Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
Review and understand the study protocol
Understand the data sources for the study, data transfer specifications, and data structure
Execute and document peer-review of CM platform setup done by other CMA colleagues
Work with the client directly to manage deliveries as part of a sponsor-dedicated project

Skills

SAS

SAS Macro

Cluepoints

Centralized Monitoring

KRI

QTL

Data Quality Assessments

Data Management

Biostatistics

Statistical Analysis

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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