Dct Implementation And Integration

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
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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 delivery by ensuring requirements, specific