Manager, Central Monitoring

🔥 15 hours ago

🌐 Poland, Serbia – Remote

🇵🇱 Poland – Remote 🇷🇸 Serbia – Remote

💵 zł300k - zł320k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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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 developing and refining the Study Quality Risk Assessment and Control Tracker to identify and manage study risks • Lead creation of the Central Monitoring Plan aligned with study-specific needs and RBQM methodologies • Configure, implement, and execute the Central Monitoring RBQM system across assigned studies with data analysts • Conduct study-level Central Monitoring Reviews using data analysis tools • Interpret KRIs/KPIs and assess trends to identify areas requiring intervention • Present findings to clinical study teams and support root cause analysis • Provide recommendations for follow-up actions addressing identified risks • Document Central Monitoring Review outputs and track decisions and action closure • Act as Central Monitoring subject matter expert during audits, inspections, and within study teams • Partner with outsourcing management to oversee CRO Central Monitoring activities • Evaluate processes and recommend improvements to tools, metrics, and methodologies • Represent Central Monitoring in cross-functional process improvement initiatives • Assess emerging technologies to enhance Central Monitoring capabilities • Support several studies within a therapeutic area and at program level • Collaborate with Central Monitors and Centralized Data Risk Analysts

🎯 Requirements

• High School Diploma, Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, or Board Certified MD • At least 7 years of relevant experience in the biotechnology/pharmaceutical industry • Minimum of 1 year of direct Central Monitoring experience • Strong analytical problem-solving and critical thinking abilities • 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 • Ability to identify and interpret current and future business trends and apply them to centralized monitoring practices • Excellent written communication skills • Aptitude for mathematical concepts, statistical methodologies, and data analytics • Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures • Proficiency in Microsoft Office applications, with advanced Excel skills for data manipulation and reporting • Experience using CluePoints is preferred

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • People who motivate and face challenges together • Innovative technology • Excellent training • Annual performance-based bonus plan for eligible roles • Annual salary review for eligible roles • Total rewards incentives for eligible roles • Flexible work arrangements • Professional development • Up to 25% travel requirement

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