Senior eClinical Business Lead, IRT & DHT Design Consultant

Accountabilities: The Senior eClinical Business Lead, IRT & DHT Design Consultant will provide strategic and technical guidance for clinical trial technology solutions, ensuring systems meet study requirements and industry standards. Key responsibilities include: Advising project leaders and study team members on RTSM (Randomization and Trial Supply Management) and DHT (Digital Health Technology) study design. Reviewing clinical protocols and collaborating with stakeholders to define, analyze, and validate user requirements. Identifying potential risks related to RTSM and DHT design and recommending effective mitigation strategies. Translating complex technology requirements into clear, understandable information to support study team decision-making. Evaluating system integrations and proactively identifying potential requirements or functionality challenges. Collaborating with UAT teams to support testing activities and successful system implementation. Maintaining awareness of evolving RTSM, DHT, and clinical trial technology trends and applying industry best practices. Ensuring quality control, timely delivery of project outputs, and appropriate resolution of issues. Engaging with external clients to discuss study design, protocol requirements, and technology solutions. Applying knowledge of ICH guidelines, Good Clinical Practices (GCP), and relevant clinical research standards. Completing administrative responsibilities, training requirements, and documentation activities accurately and on time. Requirements: The ideal candidate brings extensive experience in clinical technology solutions, strong consulting capabilities, and the ability to manage complex projects in a regulated environment. Required qualifications and skills include: 5+ years of experience building RTSM and/or DHT clinical trial systems, including requirements gathering, configuration, design, and user acceptance testing. Strong technical knowledge and experience working with clinical trial data standards. Experience applying data standards within clinical research environments; knowledge of CDISC SDTM is preferred. Ability to create, document, and communicate business processes and train stakeholders effectively. Strong analytical, problem-solving, and root cause analysis skills. Ability to independently resolve issues, apply sound judgment, and escalate when appropriate. Client-focused mindset with the ability to build and maintain trusted relationships. Knowledge of ICH and GCP regulations across relevant regions. Strong leadership skills with the ability to prioritize tasks and manage workload effectively. Excellent interpersonal, written, and verbal communication skills. Deep understanding of clinical research processes, clinical technologies, RTSM design, and system requirements. Experience with eCOA or ePRO solutions is considered an advantage. Bachelor’s degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience. Benefits: The role offers the opportunity to contribute to meaningful healthcare innovation while working in a global and collaborative environment. Benefits include: Remote work opportunity based in India. Full-time employment within a global clinical research environment. Opportunity to support impactful clinical trials and healthcare advancements. Collaboration with international teams and industry experts. Exposure to innovative clinical technology platforms and digital health solutions. Opportunities for professional growth and continuous learning. A role combining technical expertise, consulting, and strategic problem-solving. A mission-driven environment focused on improving patient outcomes.