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Senior eClinical Business Lead, IRT – DHT Design Consultant
ParexelSenior eClinical Business Lead supporting clinical research activities to advance new treatments at Parexel. Collaborating with cross-functional teams on RTSM and DHT design and clinical trial optimization.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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 that align with study design objectives and regulatory standards
- Identify, assess, and mitigate risks related to RTSM and DHT implementation, ensuring compliance with clinical trial processes and data integrity standards
- Translate complex technical and business requirements into clear, actionable guidance for study teams and system users to facilitate informed decision-making
- Evaluate system integrations and proactively identify potential issues with third-party interfaces, data flows, and user requirements to ensure seamless functionality
- Partner with UAT leads to design, execute, and validate testing protocols, ensuring systems meet defined requirements and business objectives
- Stay current on emerging RTSM and DHT technologies, industry best practices, and regulatory developments to drive continuous improvement and innovation
- Manage quality assurance and timely delivery of project deliverables while implementing corrective actions to maintain excellence
- Interact with external clients to discuss RTSM and DHT design considerations, protocol requirements, and implementation strategies
- Demonstrate proactive problem-solving and deliver timely, effective solutions to client challenges and technical issues
Requirements
What you’ll need- 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
Benefits
Comp & perks- Health insurance
- Flexible working arrangements
- Professional development opportunities