Senior eClinical Business Lead, IRT – DHT Design Consultant

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Provide consultation to Project Leaders and other study team members on RTSM and DHT study design • Analyze protocols and collaborate with all stakeholders to create and review user Requirements • Identify and mitigate any risks related to RTSM and DHT study design • Translate complex RTSM and DHT requirement descriptions into language that can be understood by study team • Understand the various integrations that can interface with RTSM and DHT • Work closely with UAT Leads • Stay current on RTSM and DHT technology and relevant clinical trial process developments • Manage quality control and timely delivery of project deliverables

🎯 Requirements

• 5+ years of experience in building RTSM and/or DHT clinical trial systems • Excellent technical and data standard experience • Proven awareness and experience in the use of data standards within a clinical trial environment • Ability to create and explain business process and train others on that process • Strong analytical and problem-solving skills • Ability to resolve issues independently • Client focused and demonstrating an ability to create and maintain trust with the client • Knowledgeable in ICH and GCP regulations in relevant geographies • Personal leadership, prioritization and management of own workload • Knowledge in clinical research industry, including expert understanding of clinical technology, RTSM design, and system requirements • eCOA, ePRO experience is a plus.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development