Senior eClinical Business Lead, IRT & DHT Design Consultant
Parexel
IndiaremotePosted 1 month ago
Skill Required
EClinical-LeadIRT-SpecialistDHT-ConsultantClinical-Systems-ConsultantClinical-Trial-ManagerEClinical-Solutions-DesignerEClinical-Business-LeadSenior-Healthcare-Technology-ConsultantSenior-Clinical-Solutions-EngineerSenior-Healthcare-IT-ArchitectDigital-Health-Consultantdesignrelated fieldanalyticaldevelopingbuildingTestNGGCPandManual TestingFulltime
Key highlights
- 5+ years of experience building RTSM and/or DHT clinical trial systems
- Bachelor's degree in Life Sciences, Computer Science, or related field (or equivalent experience)
- Deep expertise in RTSM and DHT systems and requirements management
- Flexible work environment with growth and learning opportunities
- Work with emerging RTSM and DHT technologies and industry best practices
- Collaborative, patient‑focused culture
Role overview
Parexel seeks a Senior eClinical Business Lead (IRT and DHT Design Consultant) to support clinical research activities that advance new treatments for patients. The role is central to RTSM and digital health technology (DHT) study design, requirements analysis, stakeholder collaboration, and clinical trial optimization, working from study planning through closeout. The senior lead will provide expert consultation, translate complex requirements into actionable solutions, and ensure seamless integration across clinical trial systems while contributing to a fast‑paced, growth‑oriented environment focused on technology innovation, study efficiency, and patient engagement.
Responsibilities
- Provide expert consultation to project leaders and study teams on RTSM and DHT study design, requirements gathering, and system configuration
- Analyze protocols and collaborate with stakeholders to develop, review, and validate user requirements that align with study design objectives and regulatory standards
- Identify, assess, and mitigate risks related to RTSM and DHT implementation, ensuring compliance with clinical trial processes and data integrity standards
- Translate complex technical and business requirements into clear, actionable guidance for study teams and system users to facilitate informed decision‑making
- Evaluate system integrations and proactively identify potential issues with third‑party interfaces, data flows, and user requirements to ensure seamless functionality
- Partner with UAT leads to design, execute, and validate testing protocols, ensuring systems meet defined requirements and business objectives
- Stay current on emerging RTSM and DHT technologies, industry best practices, and regulatory developments to drive continuous improvement and innovation
- Manage quality assurance and timely delivery of project deliverables while implementing corrective actions to maintain excellence
- Interact with external clients to discuss RTSM and DHT design considerations, protocol requirements, and implementation strategies
- Demonstrate proactive problem‑solving and deliver timely, effective solutions to client challenges and technical issues
Requirements
- Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience
- 5+ years of experience in building RTSM and/or DHT clinical trial systems, developing user requirements, and managing requirements gathering, configuration, design, and user acceptance testing
- Knowledge of ICH‑GCP, regulatory requirements, and clinical trial processes
- Excellent technical and data standards knowledge with proven experience applying data standards in clinical trial environments
- Demonstrated ability to create and explain business processes and train others on implementation
- Strong communication, organization, and problem‑solving skills
- Deep expertise in RTSM and DHT systems, clinical trial design, and requirements management
- Strong analytical and problem‑solving abilities with the capacity to work independently and escalate appropriately
- Experience working in clinical research, healthcare, or a regulated environment
- Exceptional ability to collaborate across teams and communicate complex concepts clearly to diverse audiences
- Patient‑focused mindset with strong attention to detail and commitment to data integrity
- Comfort working with RTSM platforms, digital health technology (DHT) solutions, and clinical trial management systems (CTMS)
Nice to have
- Knowledge of industry standards such as CDISC SDTM and other data standards relevant to clinical trials
- Experience with eCOA or ePRO systems and digital health technology platforms
- Proven track record of conducting root cause analysis and driving process improvement initiatives
- Demonstrated client‑focused approach with ability to build and maintain strong client relationships
Benefits
- Flexible work environment
- Opportunities for professional growth and continuous learning
- Exposure to emerging RTSM and DHT technologies
- Collaborative, diverse team environment
- Career path expansion across clinical research and digital health innovation
- Supportive culture that values empathy and making a difference
Additional details
- Parexel is a leading global clinical development partner with 22,000+ employees worldwide, delivering insights‑driven clinical and consulting solutions to the life sciences industry.
- The company's mission is to improve the world's health by designing patient‑focused clinical trials that broaden access and make research a care option for anyone, anywhere.
- The role is part of a fast‑paced, growth‑oriented team that embraces bold thinking, adapts quickly to change, and raises the bar for speed and quality of clinical research.
- Originally posted on Himalayas.
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