Senior eClinical Business Lead, IRT – DHT Design Consultant

This is a fully remote position, open to applicants in India.

📋 Description

• Deliver expert advice on RTSM and DHT study design, requirements gathering, and system setup.

• Review protocols and engage with stakeholders to create, assess, and confirm user requirements that meet study goals and regulatory criteria.

• Recognize, evaluate, and mitigate risks associated with RTSM and DHT implementation while ensuring compliance and data accuracy.

• Convert technical and business requirements into practical guidance for study teams and system users.

• Assess system integrations, third-party connections, data flows, and user needs.

• Collaborate with UAT leads to design, carry out, and validate testing protocols.

• Stay updated on emerging RTSM and DHT technologies, industry standards, and regulatory changes.

• Oversee quality assurance and ensure timely completion of project deliverables; enact corrective measures when necessary.

• Engage with external clients concerning RTSM and DHT design, protocol specifications, and implementation strategies.

• Address client challenges and technical issues with prompt and effective solutions.

• Support clinical study operations from planning through to closeout.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Computer Science, or a related discipline, or equivalent professional experience.

• Over 5 years of experience in developing RTSM and/or DHT clinical trial systems, creating user requirements, and overseeing requirements gathering, configuration, design, and user acceptance testing.

• Familiarity with ICH-GCP, regulatory standards, and clinical trial processes.

• Strong technical knowledge and data standards expertise, with a proven track record of applying data standards in clinical trial settings.

• Ability to articulate and develop business processes and train others on implementation.

• Excellent communication, organizational, and problem-solving abilities.

• Extensive knowledge of RTSM and DHT systems, clinical trial design, and requirements management.

• Experience in clinical research, healthcare, or a regulated environment.

• Comfort with RTSM platforms, digital health technology solutions, and clinical trial management systems (CTMS).

• Preferred: Familiarity with CDISC SDTM and other clinical trial data standards.

• Preferred: Experience with eCOA or ePRO systems and digital health technology platforms.

• Preferred: Experience in root cause analysis and process improvement.

• Preferred: Experience in building client relationships.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for growth.

• Continuous learning opportunities.

• Career paths within clinical research and digital health innovation.