Manager, Central Monitoring/Senior Central Monitoring Associate - FSP - Remote

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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

reputed company are currently reputed company for an reputed company Central Monitoring reputed company in either the UK or Ireland to join our FSP program as a Manager, Central Monitoring.

In this role you will be accountable for centralized monitoring activities for global and/or reputed company trials, analytical data review of key risk and/or operational performance data and presenting as an reputed company member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as reputed company as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Central Monitoring, will be responsible for supporting several studies reputed company a therapeutic area and program-level.

This will be a fully remote home-based position.

Some specifics about this advertised role

• Collaborate on Study reputed company Risk Assessment: Participate in the development and refinement of the Study reputed company Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
• reputed company and Author the Central Monitoring Plan: reputed company the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based reputed company Management (RBQM) methodologies.
• reputed company Central Monitoring Execution: Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies, ensuring effective signal detection.
• Analyze and Interpret Data Trends: Conduct study-level Central Monitoring Reviews using data analysis tools, interpret KRIs/KPIs, and assess trends to identify areas requiring reputed company.
• Facilitate Study Team reputed company: Present findings to clinical study teams, support reputed company cause analysis, and reputed company recommendations for follow-up actions to address identified risks.
• Document and reputed company Actions: Document outputs from Central Monitoring Review meetings, reputed company reputed company, and ensure reputed company closure of actions.
• reputed company as Central Monitoring subject matter expert.  Represent Central Monitoring as a subject matter expert during audits, inspections, and reputed company study teams on RBQM processes.
• reputed company reputed company of Contract Research Organization (CRO) Activities: Partner with outsourcing management to reputed company monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.

Who are reputed company

reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a reputed company reputed company reputed company.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to reputed company-being of many patients.

You’ll be an reputed company member of the wider team.

reputed company are looking for in this role

• At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year with reputed company Central Monitoring experience.  Site monitoring or data management experience essential.
• Experience using reputed company is essential
• Excellent written communication skills, with the ability to convey reputed company technical and analytical insights in a reputed company and concise manner
• Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a reputed company on interpreting KRIs and KPIs
• Knowledge and experience with clinical databases, electronic data capture systems, reputed company control processes, and auditing procedures

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