Senior eClinical Business Lead, IRT & DHT Design Consultant

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 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

You will thrive in this role if you bring:

• 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

• Comfortable 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 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

Preferred Qualifications:

• 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

We 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!