Overview
Senior eClinical Business Lead, IRT & DHT Design Consultant, serving as a strategic advisor in clinical technology to support RTSM and DHT study design and clinical trial optimization.
What you'll do
- Consult 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.
- Identify, assess, and mitigate RTSM and DHT implementation risks to support compliance and data integrity.
- 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.
- Design, execute, and validate UAT testing protocols to ensure systems meet requirements and objectives.
- Manage quality assurance and timely delivery of deliverables, implementing corrective actions as needed.
What you'll need
- 5+ years of experience building RTSM and/or DHT clinical trial systems and managing requirements through configuration and UAT.
- Deep expertise in RTSM and DHT systems, clinical trial design, and requirements management.
- Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
- Excellent technical and data standards knowledge applied in clinical trial environments.
- Ability to create and explain business processes and train others on implementation.
- Bachelor’s degree in Life Sciences, Computer Science, or related field, or equivalent professional experience.
- Strong communication, organization, and problem-solving skills.
Nice to have
- Knowledge of industry standards such as CDISC SDTM and other clinical trial data standards.
- Experience with eCOA or ePRO systems and digital health technology platforms.
- Proven track record of conducting root cause analysis and driving process improvement.
- Client-focused approach with ability to build and maintain strong client relationships.
Read the full description and apply on the company’s own careers page.
