DCT Implementation and Integration
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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, including the business analysis needed to define and deliver third-party Study Hub integrations.
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, ensuring Study Hub is designed, tested, and deployed ready for First Site Activation.
Positioning
While the DCTL owns overall study delivery, the DCT Design & Implementation Lead owns technical strategy, business requirements translation, integration specification, build quality, and implementation execution for Study Hub and its integrated systems.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.
- Act as the technical authority for Study Hub capabilities and constraints in study‑level discussions.
- Work with clients and business users to elicit, document, and validate requirements for third‑party Study Hub integrations, ensuring specifications are clear, testable, and aligned to operational delivery needs.
- 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, including:
- Development of UAT scripts
- Coordination of internal and external testing
- Management of testing timelines and issue resolution
- Collaborate with integrated systems teams and Study Hub Delivery Support to orchestrate multi‑system configuration and testing.
- Coordinate with internal IQVIA engineering teams and third‑party engineering functions on integration delivery plans, technical specifications, dependencies, timelines, defect resolution, and release readiness.
- Oversee Study Hub Go‑Live, ensuring readiness for First Site Activation.
- 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 behaviours, business rules, technical dependencies, testing expectations, and quality control checkpoints.
- Act as the bridge between client stakeholders, business users, Study Hub delivery teams, IQVIA engineering, and third‑party vendors to ensure requirements are understood, feasible, and deliverable within agreed timelines.
- Support integration testing, defect triage, validation evidence review, and release readiness activities to confirm that delivered functionality meets approved specifications and business user needs.
- 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.
- Ensure technical decisions are aligned with operational delivery needs and site usability considerations.
- Serve as a key technical liaison between sponsors, delivery teams, and platform teams.
- 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.
- Ensure changes are implemented in a controlled, validated, and timely manner.
- 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.
- Proactively identify technical risks and mitigation strategies related to Study Hub design and implementation.
- Support inspection readiness related to Study Hub configuration and implementation.
- Embed quality control into integration