Senior eClinical Business Lead, IRT, DHT Design Consultant

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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

• Provide expert consultation to project leaders and study teams on RTSM and DHT study design, requirements gathering, and system configuration • Analyze protocols and collaborate with stakeholders to develop, review, and validate user requirements aligned with study objectives and regulatory standards • Identify, assess, and mitigate risks related to RTSM and DHT implementation • Translate complex technical and business requirements into actionable guidance for study teams and system users • Evaluate system integrations and identify issues with third-party interfaces, data flows, and user requirements • Partner with UAT leads to design, execute, and validate testing protocols • Monitor emerging RTSM and DHT technologies, industry best practices, and regulatory developments • Manage quality assurance and timely delivery of project deliverables, implementing corrective actions • Interact with external clients regarding RTSM and DHT design, protocol requirements, and implementation strategies • Provide timely solutions to client challenges and technical issues

🎯 Requirements

• Deep expertise in RTSM and DHT systems, clinical trial design, and requirements management • Strong analytical and problem-solving abilities; ability to work independently and escalate appropriately • Experience in clinical research, healthcare, or a regulated environment • Ability to collaborate across teams and communicate complex concepts clearly • Strong attention to detail and commitment to data integrity • Comfortable working with RTSM platforms, DHT solutions, and clinical trial management systems (CTMS) • Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience • 5+ years of experience building RTSM and/or DHT clinical trial systems and managing requirements gathering, configuration, design, and user acceptance testing • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Technical and data standards knowledge, including applying data standards in clinical trial environments • Ability to create and explain business processes and train others on implementation • Strong communication, organization, and problem-solving skills • Preferred: Knowledge of CDISC SDTM and other clinical-trial data standards • Preferred: Experience with eCOA or ePRO systems and digital health technology platforms • Preferred: Root cause analysis and process improvement experience • Preferred: Client relationship management experience

🏖️ Benefits

• Flexible work arrangements • Continuous learning opportunities • Career path exploration and expertise expansion • Growth-oriented environment • Diverse teams • Opportunity to contribute to meaningful clinical research and digital health innovation