DCT Implementation and Integration

124k - 230.3k PLN124 000 - 230 300 PLN/ rok./ rok.

NieokreśloneHybryda·WarszawaFull-time

#464120·Dodano 3 dni temu·0

Źródło: IQVIA

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Tech Stack / Keywords

Study HubUser Acceptance TestingUATDigital Clinical TrialsSoAsystem configurationintegration specificationsdata flowsvalidationclinical systems

Podsumowanie oferty

Own the technical design, configuration, implementation, and integration readiness of Study Hub for decentralized and hybrid clinical trials. Translate protocol and business requirements into integration specifications, and lead testing and deployment readiness for First Site Activation.

Wymagania

Minimum Qualifications:

Bachelor’s degree in Life Sciences, Technology, or a related field.
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 communication 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:

Strong planning and prioritization skills.
Detail-oriented with a strong quality mindset.
Learning agility and commitment to continuous improvement.

Obowiązki

Technical Strategy & Study Hub Design:

Partner with the DCTL to translate protocol, Schedule of Activities, and patient engagement objectives into a technical design for Study Hub.
Own the technical strategy and architecture for each Study Hub instance, aligned with study delivery plans.
Ensure the design supports protocol requirements, participant journeys, and integrated system dependencies.
Act as the technical authority on Study Hub capabilities and constraints.
Elicit, document, and validate requirements for third-party Study Hub integrations.

Study Hub Build & Implementation Execution:

Lead the Study Hub build lifecycle from design through configuration and deployment.
Plan and execute User Acceptance Testing (UAT), including developing scripts, coordinating testing, and managing timelines and issue resolution.
Coordinate multi-system configuration and testing with integrated systems teams and Study Hub Delivery Support.
Coordinate integration delivery plans, specifications, dependencies, timelines, defect resolution, and release readiness with internal engineering teams and third-party engineering functions.
Oversee Study Hub Go-Live and readiness for First Site Activation.

Business Analysis & Third-Party Integration Delivery:

Lead integration business analysis, including requirements discovery, workflow mapping, user story development, acceptance criteria, and traceability.
Develop and maintain integration specifications covering data flows, system behaviours, business rules, technical dependencies, testing expectations, and quality control checkpoints.
Bridge client stakeholders, business users, delivery teams, engineering, and third-party vendors to align requirements and delivery timelines.
Support integration testing, defect triage, validation evidence review, and release readiness.

Cross-Functional & Technical Collaboration:

Work with DPS, PRE, integrated systems teams, and DCT Super Users to resolve technical challenges.
Guide the Super User team on Study Hub design inputs from Train environment through Production Go-Live.
Align technical decisions with operational delivery needs and site usability.
Serve as a 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 affecting 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 with client expectations.
Identify technical risks and mitigation strategies related to Study Hub design and implementation.
Support inspection readiness related to Study Hub configuration and implementation.
Ensure integration requirements, specifications, test evidence, defects, and approvals are documented and traceable.

IQVIA

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