Manager, Central Monitoring

🔥 0 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

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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

• Lead centralized monitoring activities for global and complex clinical trials • Review key risk and operational performance data • Present insights as an integral member of clinical study teams • Combine KRI and KPI data from analytical tools with supplemental operational data and trends • Support identification and resolution of issues requiring intervention • Support several studies within a therapeutic area and at the program level • Collaborate with Central Monitors and Centralized Data Risk Analysts to identify, conduct, and report central monitoring activities • Participate in developing and refining the Study Quality Risk Assessment and Control Tracker (QRACT) • Develop and author Central Monitoring Plans aligned with study needs and RBQM methodologies • Work with data analysts to configure, implement, and execute Central Monitoring RBQM systems • Conduct study-level Central Monitoring Reviews and interpret KRIs, KPIs, and trends • Present findings, support root cause analysis, and recommend follow-up actions • Record meeting outputs, track decisions, and ensure timely action closure • Represent Central Monitoring during audits, inspections, and within study teams • Oversee CRO Central Monitoring activities with outsourcing management • Evaluate processes and recommend improvements to tools, metrics, and methodologies • Contribute to cross-functional initiatives and assess emerging technologies • Travel up to 25% may be required

🎯 Requirements

• Strong analytical problem-solving and critical thinking abilities • Experience troubleshooting data refreshes and resolving execution errors in analytical systems • 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 • Ability to convey complex technical and analytical insights clearly and concisely • Aptitude for mathematical concepts, statistical methodologies, and data analytics • Proficiency in Microsoft Office applications • Advanced Excel skills for data manipulation and reporting • Bachelor's degree • At least 7 years of relevant experience in the biotechnology/pharmaceutical industry • Minimum of 1 year of direct Central Monitoring experience • Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements • Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and auditing procedures • Experience using CluePoints or similar centralized monitoring RBQM systems is preferred • Site monitoring or data management experience

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training • Flexibility • Growth opportunities

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