Senior eClinical Business Lead, IRT & DHT Design Consultant

Job description

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **Key Accountabilities:** **Project Delivery** - Provide consultation to Project Leaders and other study team members on RTSM and DHT (Digital Health Technology) study design. - Analyze 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. **Client Management** - 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. **General Administration** - Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices. - Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines. **Skills and Experience:** - 5+ years of experience in building RTSM and/or DHT clinical trial systems and developing user requirement with detailed understanding of requirements gathering, configuration, design, and user acceptance testing. - Excellent technical and data standard experience. - Proven awareness and experience in the use of data standards within a clinical trial environment; knowledge of industry standards such as CDISC SDTM is preferred. - Ability to create and explain business process and train others on that process. - Strong analytical and problem-solving skills. - Ability to resolve issues independently with good judgement to escalate appropriately. - Client focused and demonstrating an ability to create and maintain trust with the client. - Knowledgeable in ICH and GCP regulations in relevant geographies. - Personal leadership, prioritization and management of own workload. - Ability to conduct root cause analysis in business problem solving and process improvement development. - Excellent interpersonal, verbal, and written communication skills. - Knowledge in clinical research industry, including expert understanding of clinical technology, RTSM design, and system requirements. - eCOA, ePRO experience is a plus. **Education:** - Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent experience.