d) at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Master’s or higher-level degree in life sciences OR several years of equivalent professional education
Solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities
Fluent in English (written and spoken)
Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action
Demonstrates active listening skills and cultural awareness
Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors

Responsibilities

Plan trial quality and risk monitoring/mitigation as part of the Trial Team
Deliver Risk-based Site Monitoring approach and training for the trial
Accountable for the development of the operational Site Monitoring & Oversight plans
Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates
Act as an expert and consultant on Site management and monitoring topics
Integrate patient/site level feedback to the documents ensuring design with a focus on the patient
Provide timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee)
Facilitate communication and direction with CT Managers and IQVIA CRAs
Monitor progress and oversee Site Management and Monitoring activities conducted by IQVIA partners during clinical trial conduct including adherence to ICH-GCP and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans
Pre-identification of important protocol deviations from site deviations
Continuous review, risk identification, evaluation and communication on a trial level
Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits)
Facilitate communication and training related to site monitoring in the trial
Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries
Support compilation and review of the quality section for the clinical trial report for site monitoring activities

Skills

Site Monitoring

Risk Assessment

Clinical Trial Management

Oversight Planning

Trend Analysis

Signal Detection

Trial Quality Management

Risk-based Monitoring

CRA Training

Protocol Compliance

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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