Senior eClinical Business Lead, IRT – DHT Design Consultant

🔥 9 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

✍️ Designer

👻 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

• Provide expert consultation 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 RTSM and DHT implementation risks while ensuring compliance and data integrity • Translate technical and business requirements into actionable guidance for study teams and system users • Evaluate system integrations, 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; implement corrective actions • Interact with external clients regarding RTSM and DHT design, protocol requirements, and implementation strategies • Solve client challenges and technical issues with timely, effective solutions • Contribute to clinical study operations from planning through closeout

🎯 Requirements

• Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience • 5+ years of experience in building RTSM and/or DHT clinical trial systems, developing user requirements, and managing requirements gathering, configuration, design, and user acceptance testing • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Excellent technical and data standards knowledge with proven experience applying data standards in clinical trial environments • Demonstrated ability to create and explain business processes and train others on implementation • Strong communication, organization, and problem-solving skills • Deep expertise in RTSM and DHT systems, clinical trial design, and requirements management • Experience working in clinical research, healthcare, or a regulated environment • Comfort working with RTSM platforms, digital health technology solutions, and clinical trial management systems (CTMS) • 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-building experience

🏖️ Benefits

• Flexibility in work arrangements • Growth opportunities • Continuous learning opportunities • Career paths across clinical research and digital health innovation