Job Description

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.