Manager, Central Monitoring

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🔥 1 hour ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Participate in the development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT) to identify and manage study risks • Lead the creation of Central Monitoring Plans aligned with study-specific needs and Risk Based Quality Management methodologies • Work with data analysts to configure, implement, and execute the Central Monitoring RBQM system across assigned studies • Conduct study-level Central Monitoring Reviews using data analysis tools • Interpret KRIs/KPIs and assess data trends to identify areas requiring intervention • Present findings to clinical study teams, support root cause analysis, and provide recommendations for follow-up actions • Document Central Monitoring Review meeting outputs, track decisions, and ensure timely closure of actions • Act as a Central Monitoring subject matter expert during audits, inspections, and within study teams • Partner with outsourcing management to align monitoring strategies and oversee CRO execution of Central Monitoring activities • Evaluate Central Monitoring processes and recommend improvements to tools, metrics, and methodologies • Represent Central Monitoring in cross-functional process improvement initiatives and assess emerging technologies

🎯 Requirements

• Strong analytical problem-solving and critical thinking abilities, with experience troubleshooting data refreshes and resolving execution errors in analytical systems • Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements • Effective communication and interpersonal skills; ability to build relationships internally and externally • Demonstrated ability to identify and interpret current and future business trends and apply them to centralized monitoring practices • 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 • Proficiency in Microsoft Office applications, with advanced skills in Excel for data manipulation and reporting • Experience using CluePoints or similar centralized monitoring system preferred • High School Diploma, Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, or Board Certified MD listed as minimal educational requirements • At least 7 years of relevant experience in the biotechnology/pharmaceutical industry • Minimum 1 year of direct Central Monitoring experience • Site monitoring or data management experience is a plus

🏖️ Benefits

• No benefits, perks, or compensation extras are specified in the posting.

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