DCT Implementation and Integration Lead
IQVIA · Sofia
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, specifications, test evidence, defects, and approvals are documented and traceable.
Principal Interactions
- DCTL / DTA
- Sponsor and Clinical Teams
- DPS and Integrated Systems Teams
- Internal IQVIA Engineering and Product Teams
- Third-Party Engineering and Technology Partners
- DCT Super Users
- PRE and Study Delivery Teams
What to Expect from Your DCT Design & Implementation Lead
- Deep understanding of Study Hub technical capabilities and integrated system behavior.
- Strong commitment to customer success, delivery quality, and on‑time execution.
- Ability to translate complex protocol requirements into practical, scalable technical solutions.
- Strong business analysis capability, with the ability to turn client needs into clear integration specifications, user stories, acceptance criteria, test plans, and quality control expectations.
- Clear ownership and accountability for Study Hub design and implementation outcomes.
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.
- Experience gathering business requirements, documenting technical or integration specifications, and supporting delivery with engineering or vendor teams.
- Strong understanding of clinical trial delivery and the role of technology in decentralized models.
Preferred Qualifications & Competencies
Technical & Delivery Skills
- 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.
- Ability to document and manage integration requirements, data flows, user stories, acceptance criteria, test cases, defects, and delivery dependencies.
Collaboration & Leadership
- Proven ability to work cross‑functionally across technical, operational, and sponsor teams.
- Clear, confident communicator of technical concepts to non‑technical stakeholders.
- Comfort working directly with clients, business users, engineering teams, and third-party vendors to align expectations, clarify requirements, and manage delivery timelines.
- Strong problem‑solving skills and comfort operating in dynamic delivery environments.
Personal Effectiveness
- Highly organized with strong planning and prioritization skills.
- Detail‑oriented with a strong quality mindset.
- Learning agility and commitment to continuous improvement.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.