Senior Specialist, Data Architect

Description

This senior role sits in the Data Integration and Automation group within the Global Data Management & Standards (GDMS) team. You will lead, or build yourself, the integration and upkeep of clinical databases and clinical operational systems.

You will set up clinical study systems and their transformations, connect data across systems, and hold that work to company standards. You will also handle escalations and dependencies, keep service levels and audit readiness on track, guide staffing, mentor teams, maintain SOPs and work instructions, and support training as a subject matter expert.

Responsibilities

• Design and deploy clinical technology solutions such as electronic data capture (EDC), randomization and trial supply management (RTSM), and electronic clinical outcome and patient-reported outcome tools (eCOA/ePRO), using programming, reporting frameworks and automation tools.
• Build and validate complex data logic, including edit checks, derivations and dynamic rules, with scripting and validation frameworks suited to each task.
• Evaluate and adopt tools that speed up design, build and validation.
• Serve as the in-house expert, giving technical guidance and reviews to peers and stakeholders.
• Use data literacy to shape transformation strategies that produce actionable insight.
• Create advanced reports, such as dashboards, listings and visual analytics, using reusable components and role-based access.
• Design and improve integration architecture across data sources and transformation workflows.
• Monitor data ingestion and consumption, troubleshoot faults, and improve reliability.
• Automate data engineering work to gain efficiency and reduce risk.
• Turn business needs into data and system requirements with stakeholders.
• Build robust data models, semantic layers and curated datasets, and oversee pipelines with quality checks.
• Check that systems work and comply with SOPs and regulations, set documentation standards, and identify process gaps.
• Lead test strategies, automate validation, and keep traceability from requirements to evidence.
• Lead or join process improvement and cross-functional projects.
• Mentor junior colleagues, share best practice, and support onboarding and training.
• Lead or support releases across data management and clinical operations environments, including change control and risk assessment.
• Convert requirements into technical specifications, lead user acceptance testing (UAT), gather feedback, and raise reporting standards.
• Turn data findings into clear, actionable stories for others.
• Be a dependable partner to GDMS and other cross-functional teams: seek input, align priorities and close feedback loops.

Requirements

• Expert in SQL, Python, SAS and R for building clinical data collectors, integrations, transformations, reports and visualizations.
• Experience making EDC platforms, data integration environments, clinical operations systems and cloud computing platforms work together.
• Advanced grasp of requirements, testing, validation and change control in a regulated setting, and how they apply to data management tools and clinical operations solutions.
• Deep knowledge of the clinical data lifecycle, from design and collection through cleaning, integration and reporting, and how it supports trial delivery and regulatory submissions.
• Ability to contribute to system development lifecycle management and system validation.
• Strong knowledge of common clinical and regulatory data standards and clinical operational data models, with the ability to design or review structures, mappings and controls that are consistent and reusable.
• Experience using automation, scripting or digital tools to reduce manual data management effort.
• Knowledge of the drug discovery process, FDA regulations, and GxP and ICH guidelines.
• Ability to connect business outcomes to technical deliverables.
• Communicate and negotiate well, orally and in writing, with technical and business partners and external providers. Adapt to the audience and explain technical topics to non-technical people.
• Run day-to-day work, drive issues to closure and coordinate stakeholders. Prioritize independently, escalate with context, impact and a recommendation, give clear status updates, and keep decision logs.
• Mentor junior team members on tools, checks, documentation quality and best practice.
• Make sound decisions using quantitative and qualitative information, weighing multiple options and their implications. Motivate teammates, promote open discussion, build self-awareness, and coach others.
• Qualifications: a non-degree candidate needs a minimum of 8 years of experience in clinical data programming, data engineering, or related data management or clinical operations work.
• Qualifications: an Associate's degree with a minimum of 7 years of the same experience (Minimum preferred).
• Qualifications: a Bachelor's degree with a minimum of 5 years of the same experience.
• Qualifications: an advanced degree (Master's or Doctorate) with a minimum of 2 years of experience in clinical development and/or clinical data programming, data engineering, or related data management or clinical operations work.
• Required skills: change controls, clinical databases, clinical data management, clinical development, clinical research, clinical systems, data analysis, data ingestion, data literacy, data quality assurance, data reporting, data review, data validation, integration architecture, process improvement, systems development, system validation, user acceptance testing (UAT), and vendor management.

Conditions

Regular employment with a hybrid work arrangement.

Travel is 10%.

Relocation is domestic.

Visa sponsorship is not offered.

A valid driving license is not required.

Shift is not indicated.

Hazardous materials: n/a.

The posting closes on 11/16/2026, so apply no later than 11/15/2026 (until 11:59:59 PM).