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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. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.We are seeking a Senior eClinical Business Lead, IRT and DHT Design Consultant to join our team. As a strategic advisor in clinical technology, you will 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. You will collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout. Responsibilities include providing expert consultation on digital health technology implementation, translating complex requirements into actionable solutions, and ensuring seamless integration across clinical trial systems. You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing clinical trial technology, improving study efficiency, and enhancing patient engagement. With diverse teams and continuous learning opportunities, this role offers the chance to explore career paths and expand expertise across clinical research and digital health innovation.Key Responsibilities:Provide expert consultation to project leaders and study teams on RTSM and DHT study design, requirements gathering, and system configurationAnalyze protocols and collaborate with stakeholders to develop, review, and validate user requirements that align with study design objectives and regulatory standardsIdentify, assess, and mitigate risks related to RTSM and DHT implementation, ensuring compliance with clinical trial processes and data integrity standardsTranslate complex technical and business requirements into clear, actionable guidance for study teams and system users to facilitate informed decision-makingEvaluate system integrations and proactively identify potential issues with third-party interfaces, data flows, and user requirements to ensure seamless functionalityPartner with UAT leads to design, execute, and validate testing protocols, ensuring systems meet defined requirements and business objectivesStay current on emerging RTSM and DHT technologies, industry best practices, and regulatory developments to drive continuous improvement and innovationManage quality assurance and timely delivery of project deliverables while implementing corrective actions to maintain excellenceInteract with external clients to discuss RTSM and DHT design considerations, protocol requirements, and implementation strategiesDemonstrate proactive problem-solving and deliver timely, effective solutions to client challenges and technical issuesYou will thrive in this role if you bring:Deep expertise in RTSM and DHT systems, clinical trial design, and requirements managementStrong analytical and problem-solving abilities with the capacity to work independently and escalate appropriatelyExperience working in clinical research, healthcare, or a regulated environmentExceptional ability to collaborate across teams and communicate complex concepts clearly to diverse audiencesPatient-focused mindset with strong attention to detail and commitment to data integrityComfortable working with RTSM platforms, digital health technology (DHT) solutions, and clinical trial management systems (CTMS).Required Qualifications:Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent professional experience5+ years of experience in building RTSM and/or DHT clinical trial systems, developing user requirements, and managing requirements gathering, configuration, design, and user acceptance testingKnowledge of ICH-GCP, regulatory requirements, and clinical trial processesExcellent technical and data standards knowledge with proven experience applying data standards in clinical trial environmentsDemonstrated ability to create and explain business processes and train others on implementationStrong communication, organization, and problem-solving skillsPreferred Qualifications:Knowledge of industry standards such as CDISC SDTM and other data standards relevant to clinical trialsExperience with eCOA or ePRO systems and digital health technology platformsProven track record of conducting root cause analysis and driving process improvement initiativesDemonstrated client-focused approach with ability to build and maintain strong client relationshipsWe believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™
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