Senior eClinical Business Lead, IRT & DHT Design Consultant

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.