Senior eClinical Business Lead – IRT/DHT Design

November 6

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Parexel

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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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Provide consultation to Project Leaders and other study team members on RTSM and DHT study design. • Analyse protocols and collaborate with all stakeholders to create and review User Requirements and ensure they meet the needs of the study design. • 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 to aid in their decision making and understanding of project functionality. • Understand the various integrations that can interface with RTSM and DHT, and proactively help identify any potential integration user requirements issues. • Work closely with UAT Leads. • Stay current on RTSM and DHT technology and relevant clinical trial process developments in the industry and requirements within Parexel. • Manage quality control and timely delivery of project deliverables and appropriate remedial action. • Interact with external clients as needed for discussion on RTSM and DHT design and protocol elements. • Demonstrate a proactive approach to providing solutions in a timely manner. • Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices.

🎯 Requirements

• At least 12 months experience in IRT/RTSM and/or Digital Health Technology system delivery. • Ability to develop detailed awareness of Clinical Research Services, external vendor software and tools with practical knowledge of how these applications work and provide efficiency to operations. • Experience in clinical trial systems (e.g, CTMS, EDMS, EDC, IRT, reporting tools) and in configuration of these systems. • Ability to work autonomously. • Global virtual team coordination experience for trial technology set-up. • Good project management skills. • Excellent verbal and written communication skills. • Fluent English. • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. • Awareness/experience in the needs and use of data standards in clinical trial environment; if possible, knowledge of data standards such as CDISC SDTM. • In depth understanding and experience of clinical trial processes. • Demonstrated adeptness in learning new systems and function in an evolving technical environment.

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development