Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Quality Management Remote Administration KPI Management Data Management Statistical Methods Data Mining Website Monitoring Clinical Database Development Signal Handling Root Cause Analysis +6 more

Other Skills

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Quality Control
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Leadership
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Teamwork
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Analytical Thinking
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Detail Oriented
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Empathy
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Problem Solving

Roles & Responsibilities

At least 7 years of relevant experience in the biotechnology/pharmaceutical industry, with a minimum of 1 year in direct Central Monitoring experience
Site monitoring or data management experience essential
Experience using CluePoints is essential
Excellent written communication skills with ability to convey complex technical and analytical insights; strong data analytics and interpretation of KRIs/KPIs

Requirements:

Collaborate on the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks
Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and RBQM methodologies
Oversee Central Monitoring execution by configuring, implementing, and executing the RBQM system across assigned studies, ensuring effective signal detection
Analyze and interpret data trends, conduct study-level Central Monitoring Reviews, present findings to clinical study teams, and support root cause analysis and follow-up actions

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

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

Parexel are currently recruiting for an experienced Central Monitoring professional 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 complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral 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 well 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 within a therapeutic area and program-level.

This will be a fully remote home-based position.

Some specifics about this advertised role

Collaborate on Study Quality Risk Assessment: Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks.
Develop and Author the Central Monitoring Plan: Lead the creation of the Central Monitoring Plan, ensuring alignment with study-specific needs and Risk Based Quality Management (RBQM) methodologies.
Oversee 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 intervention.
Facilitate Study Team Decisions: Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions to address identified risks.
Document and Track Actions: Document outputs from Central Monitoring Review meetings, track decisions, and ensure timely closure of actions.
Act as Central Monitoring subject matter expert. Represent Central Monitoring as a subject matter expert during audits, inspections, and within study teams on RBQM processes.
Provide Oversight of Contract Research Organization (CRO) Activities: Partner with outsourcing management to align monitoring strategies and ensure CRO partners execute Central Monitoring activities according to the agreed standards.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

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

You’ll be an influential member of the wider team.

What we 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 direct Central Monitoring experience. Site monitoring or data management experience essential.
Experience using CluePoints is essential
Excellent written communication skills, with the ability to convey complex technical and analytical insights in a clear and concise manner
Aptitude for mathematical concepts, statistical methodologies, and data analytics, with a focus on interpreting KRIs and KPIs
Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures

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