Senior eClinical Business Lead, IRT & DHT Design Consultant

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior eClinical Business Lead, IRT & DHT Design Consultant based in India.** This role offers the opportunity to shape the technology and processes behind modern clinical trials. You will provide senior expertise across IRT/RTSM and Digital Health Technology (DHT) study design, requirements, and implementation. Working with clinical, technical, and client-facing teams, you will translate complex study needs into practical, compliant solutions. Your work will help improve trial efficiency, data integrity, system usability, and patient engagement. You will contribute throughout the study lifecycle, from protocol planning and requirements through testing, implementation, and closeout. The environment is fast-paced and collaborative, with exposure to evolving digital health technologies and clinical research practices. This is an opportunity to deepen your eClinical expertise while contributing to the advancement of patient-focused clinical research. ### Accountabilities - **IRT/RTSM & DHT Consulting:** Provide expert guidance to project leaders and study teams on IRT/RTSM and DHT study design, requirements gathering, configuration, and implementation. - **Requirements Management:** Analyze clinical trial protocols and collaborate with stakeholders to develop, review, and validate user requirements aligned with study objectives and applicable regulatory standards. - **Risk & Compliance:** Identify and mitigate risks associated with IRT/RTSM and DHT implementation while protecting data integrity and ensuring adherence to clinical trial processes. - **Solution Translation:** Convert complex technical and business requirements into clear, actionable recommendations that enable study teams and system users to make informed decisions. - **Systems & Integrations:** Evaluate system integrations, third-party interfaces, data flows, and user requirements to proactively identify and resolve potential functionality or implementation issues. - **Testing & Validation:** Partner with UAT leads to design, execute, and validate testing activities, ensuring solutions meet documented requirements and business objectives. - **Client Engagement:** Work directly with external clients to discuss study design considerations, protocol requirements, implementation strategies, technical challenges, and potential solutions. - **Quality & Delivery:** Maintain high standards for quality and timely delivery of project outputs, implementing corrective actions and resolving issues proactively. - **Innovation & Continuous Improvement:** Monitor emerging IRT/RTSM and DHT technologies, industry practices, and regulatory developments to identify opportunities for improved clinical trial delivery. - **Training & Knowledge Sharing:** Develop and explain business processes and support training for users and stakeholders involved in system implementation and clinical trial operations. ## Requirements - **Education:** Bachelor's degree in Life Sciences, Computer Science, or a related discipline, or equivalent professional experience. - **Clinical Systems Experience:** At least 5 years of experience building IRT/RTSM and/or DHT clinical trial systems, including requirements gathering, system configuration, design, and User Acceptance Testing. - **Domain Expertise:** Strong understanding of clinical trial design, requirements management, clinical research processes, and regulated healthcare environments. - **Regulatory Knowledge:** Working knowledge of ICH-GCP, regulatory requirements, data integrity principles, and clinical trial standards. - **Data Standards:** Strong technical and data standards knowledge, with demonstrated ability to apply relevant standards within clinical trial environments. - **IRT/RTSM & DHT Platforms:** Comfortable working with RTSM platforms, Digital Health Technology solutions, Clinical Trial Management Systems, and related clinical technologies. - **Additional Experience:** Knowledge of CDISC SDTM and other clinical data standards, as well as experience with eCOA, ePRO, or similar digital health platforms, is preferred. - **Analytical Skills:** Strong analytical, troubleshooting, root cause analysis, and problem-solving capabilities, with the ability to work independently and escalate issues appropriately. - **Communication:** Exceptional written and verbal communication skills, with the ability to explain complex technical and business concepts clearly to diverse audiences. - **Client Management:** Demonstrated ability to establish and maintain trusted client relationships and deliver a consistently client-focused experience. - **Organization & Ownership:** Strong organizational skills, attention to detail, proactive decision-making, and commitment to quality and data integrity. - **Continuous Improvement:** Proven ability to identify opportunities for process improvement and implement practical solutions that enhance efficiency and outcomes. - **Patient Focus:** A strong commitment to patient-centered clinical research and the role technology can play in improving trial experiences and accelerating access to new treatments. ## Benefits - Flexible working environment designed to support strong performance and work-life balance. - Remote working opportunity based in India. - Opportunities for continuous learning and professional development across clinical research and digital health. - Exposure to innovative IRT/RTSM, DHT, and eClinical technologies. - Opportunity to collaborate with diverse, cross-functional teams and international clients. - Career development opportunities within a global clinical research and consulting environment. - Meaningful opportunity to contribute to clinical trials and technologies that can improve patient outcomes. - Inclusive, collaborative workplace that values diverse perspectives and encourages professional growth.