Description
The DCT Design & Implementation Lead is accountable for the end-to-end technical design, configuration, implementation, and integration readiness of Study Hub for decentralized and hybrid clinical trials.
This role partners closely with the DCTL, sponsors, business users, internal IQVIA teams, and third-party technology partners to translate protocol requirements, Schedule of Activities (SoA), patient experience goals, and business user needs into clear technical specifications, integration requirements, and a robust, compliant, scalable Study Hub solution.
Key Accountabilities
- Technical Strategy & Study Hub Design
- Partner with the DCTL to convert protocol, SoA, and patient engagement objectives into a comprehensive Study Hub technical design.
- Own the technical strategy and architecture for each Study Hub instance, ensuring alignment with study delivery plans.
- Ensure Study Hub design supports complex protocol requirements, participant journeys, and integrated system dependencies.
- Study Hub Build & Implementation Execution
- Lead the end-to-end Study Hub build lifecycle, from design through configuration and deployment.
- Own User Acceptance Testing (UAT) planning and execution.
- Collaborate with integrated systems teams and Study Hub Delivery Support to orchestrate multi-system configuration and testing.
- Business Analysis & Third-Party Integration Delivery
- Lead business analysis activities for Study Hub integrations, including requirements discovery, workflow mapping, user story development, acceptance criteria, and traceability from business need through delivery.
- Develop and maintain integration specifications that clearly define data flows, system behaviors, business rules, technical dependencies, testing expectations, and quality control checkpoints.
- Cross-Functional & Technical Collaboration
- Work closely with DPS, PRE, integrated systems teams, and DCT Super Users to resolve complex technical challenges.
- Guide the Super User team on Study Hub design inputs from Train environment through Production Go-Live.
- Change Management & Ongoing Study Support
- Support the DCTL during early site startup by addressing technical concerns and assessing configuration changes based on site feedback.
- Support protocol amendments, participant engagement updates, and design changes impacting Study Hub.
- Quality, Compliance & Delivery Assurance
- Ensure Study Hub builds meet quality, validation, and compliance standards.
- Drive on-time delivery of high-quality builds aligned to client expectations.
Minimum Qualifications
- Bachelor’s degree in Life Sciences, Technology, or a related field (required).
- Relevant experience in clinical systems implementation, study technology delivery, or digital trial platforms.
- Demonstrated experience leading system configuration, UAT, and go-live activities.
Preferred Qualifications & Competencies
- Strong knowledge of Digital Clinical Trails and integrated clinical systems.
- Experience managing complex, multi-system configurations and dependencies.
- Familiarity with validation, testing, and regulated system delivery.