Senior eClinical Business Lead, IRT, DHT Design Consultant

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

📋 Description

• Deliver expert advice to project leaders and study teams regarding RTSM and DHT study design, requirements gathering, and system configuration.

• Examine protocols and collaborate with stakeholders to create, review, and validate user requirements that align with study objectives and regulatory standards.

• Identify, evaluate, and mitigate risks associated with RTSM and DHT implementation.

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

• Assess system integrations and pinpoint issues with third-party interfaces, data flows, and user requirements.

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

• Keep abreast of emerging RTSM and DHT technologies, industry best practices, and regulatory developments.

• Ensure quality assurance and timely delivery of project deliverables, implementing corrective measures as necessary.

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

• Provide prompt solutions to client challenges and technical issues.

⛳️ Requirements

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

• Strong analytical and problem-solving skills; capable of working independently while escalating issues as needed.

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

• Proficiency in collaborating across teams and communicating complex concepts clearly.

• Excellent attention to detail and a commitment to data integrity.

• Comfortable with RTSM platforms, DHT solutions, and clinical trial management systems (CTMS).

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

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

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

• Knowledge of technical and data standards, including the application of data standards in clinical trial settings.

• Capability to create and explain business processes and train others on implementation.

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

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

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

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

• Preferred: Experience in client relationship management.

🏝️ Benefits

• Flexible work arrangements.

• Continuous learning opportunities.

• Career path exploration and expertise expansion.

• Growth-oriented environment.

• Diverse teams.

• Opportunity to contribute to meaningful clinical research and digital health innovation.