Posted today · be early
Senior eClinical Business Lead, IRT & DHT Design Consultant
Parexel
IndiaremotePosted today
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)
- Flexibility and growth opportunities within a supportive culture
- Deep expertise in RTSM and DHT systems required
- Knowledge of ICH‑GCP and regulatory requirements
- Continuous learning and career path expansion across clinical research and digital health innovation
Role overview
We are seeking a Senior eClinical Business Lead (IRT and DHT Design Consultant) to support clinical research activities that advance new treatments for patients. This position plays a key role in RTSM and DHT study design, requirements analysis, stakeholder collaboration, and clinical trial optimization, collaborating with cross‑functional teams, following industry‑standard processes, and contributing to study operations from planning through closeout. The Senior eClinical Business Lead will provide expert consultation on digital health technology implementation, translate complex requirements into actionable solutions, and ensure seamless integration across clinical trial systems while working in a fast‑paced, growth‑oriented environment with opportunities for continuous learning and career development.
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
- 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)
- 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
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
- Flexibility, growth, and space to do your best work
- Access to diverse teams and continuous learning opportunities, enabling exploration of career paths and expansion of expertise across clinical research and digital health innovation
- Fast‑paced, growth‑oriented environment focused on making a meaningful impact
- Supportive culture that values empathy, patient focus, and making a difference
Additional details
- When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal – to improve the world's health.
- Each employee contributes to the development of a therapy that ultimately will benefit a patient, working with empathy and commitment to making a difference.
- Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry.
- The company has 22,000+ employees worldwide and partners with biopharmaceutical companies and research sites to design and deliver patient‑focused clinical trials.
- Parexel emphasizes focus, agility, shared purpose, urgency to address patient needs, and acceleration of new therapies.
- The organization embraces bold thinking, quick adaptation to change, and continually raises the bar for speed and quality of clinical research.
- The role was originally posted on Himalayas.
