Analytical Monitor - UK

QUK IQVIA Ltd.; England; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading clinical research organization is seeking an Analytical Monitor to oversee data analytics and risk management across multiple clinical trials. The ideal candidate will have a bachelor's degree and over 4 years of experience in the pharmaceutical industry, skilled in data analysis and regulatory guidelines. Strong collaboration with Site Managers and other stakeholders is essential. This role requires effective English communication and is not eligible for UK visa sponsorship.

Qualifications

• 4+ years of experience in Pharmaceutical, CRO or Biotech industry.
• Experience with data analysis.
• Knowledge of clinical drug development and regulatory guidelines (ICH-GCP).
• Ability to collaborate with stakeholders and plan effectively.

Responsibilities

• Conducts activities in compliance with sponsor functional SOPs.
• Facilitates effective communication and manages multiple streams.
• Performs analytical monitoring activities for clinical trials.
• Collaborates closely with Site Managers to action trends.

Skills

Data analysis

Effective communication in English

Collaboration in cross-functional teams

Education

Bachelor's degree in Health Sciences or Data Sciences

Tools

Technology platforms for data collection

Job description

Overview

The Analytical Monitor is responsible for a range of tasks that spans the areas of targeted data analytics, risk identification & mitigation at site & subject level. The Analytical Monitor is an individual contributor role that supports the execution of analytical monitoring activities that will enable Site Managers to perform guided issue/ risk management. The Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. Analytical Monitor collaborates closely with Site Managers, other Data Management & Central Monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.

Responsibilities

• Conducts activities in compliance with sponsor functional SOPs, processes and policies.
• Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed.
• May support innovation or process improvement projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools & processes.
• Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process.
• Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence
• Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level.
• Accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals
• Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.

Education and Experience Requirements/Qualifications

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences
• Approximately 4+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry
• Experience with data analysis
• Knowledge of clinical drug development within the pharmaceutical industry or related industry
• Working knowledge of regulatory guidelines (e.g., ICH-GCP).
• Experience working with technology platforms and systems used for the collection, analysis and reporting of data.
• Ability to collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.
• Ability to communicate effectively in English (written and verbal).

Preferred Experience

• Familiarity with basic risk management, project management, and/or statistical concepts.
• Basic Knowledge of Central Monitoring and Risk-based Quality Management (RBQM)/Risk-based Monitoring (RBM)/Quality by Design (QbD) concepts

Interfaces – Primary/Other

• Functional contacts include but are not limited to Site Managers, Local Trial Managers, Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• External contacts include but are not limited to External Service Providers.

This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com