Job Description
The Senior Specialist, Data Architect, GDMS Data Integration and Automation leads and/or executes the build, integration, and maintenance of clinical databases/clinical operational systems. In addition, the Senior Specialist, Data Architect enables clinical study systems setup, transformations, and data-integration activities across systems while enforcing enterprise standards. The Senior Specialist, Data Architect manages escalations and dependencies, ensures SLAs (Service Level Agreements) and audit readiness, guides resourcing, mentors teams, maintains SOPs/WIs (Standard Operating Procedures/ Work Instruction), and provides subject matter expertise support on training.
Responsibilities
Programming and reporting
- Design and deploy clinical technology system solutions (e.g., for EDC [Electronic Data Capture], RTSM [Randomization & Trial Supply Management], eCOA/ePRO [electronic Clinical Outcome Assessment/ electronic Patient-Reported Outcome]) using programming / reporting frameworks and automation tools.
- Implement and validate complex data logic (edit checks, derivations, dynamic rules) with fit-for-purpose scripting and validation frameworks.
- Recommend and implement tools to streamline design, build, and validation processes.
- Act as a domain expert, providing technical guidance and reviews to peers and stakeholders.
- Apply data literacy to design transformation strategies for actionable insights.
- Develop advanced reporting solutions (dashboards, listings, visual analytics) with reusable components and role-based access.
Data Engineering
- Define and optimize integration architecture, including data sources and transformation workflows across systems.
- Monitor and troubleshoot data ingestion and consumption to improve reliability.
- Automate and strengthen data engineering processes for efficiency and risk reduction.
- Collaborate with stakeholders to translate business needs into data and system requirements.
- Develop robust data models, semantic layers, and curated datasets; monitor pipelines and enforce quality checks.
Process
- Validate system functionality and ensure compliance with SOPs (Standard Operating Procedures) and regulations.
- Set documentation standards and identify process gaps for improvement.
- Lead testing strategies for solutions; automate validation and ensure traceability from requirements to evidence.
- Lead or participate in process improvement initiatives and cross-functional projects.
- Mentor junior colleagues, share best practices, and support onboarding and training.
- Lead or support release processes for various business needs across environments (data management/clinical operations), including change control and risk assessment.
- Align stakeholders by translating requirements into technical specs; lead UAT (User Acceptance Testing), capture feedback, and improve reporting standards.
- Partner across teams to turn data and technical findings into clear, actionable stories
- Act as a reliable partner to GDMS (Global Data Management & Standards) and other cross-functional teams, actively seeking input, aligning priorities, and closing feedback loops to drive high-quality, coordinated delivery.
Technical skills
- Expert-level proficiency in various languages including SQL, Python, SAS, and R for implementing clinical data collectors, integrations, transformations, reporting and visualizations
- Experienced in the interoperability of EDC platforms, data integration environments, clinical operations systems, and cloud computing platforms
- Advanced understanding of requirements, testing, validation, and change control in a regulated environment, and how these apply to data-management tools and clinical operations solutions.
- Deep understanding of clinical data lifecycles—from design and collection through cleaning, integration, and reporting—and how these activities support trial delivery and regulatory submissions.
- Proficiency and ability to contribute in System Development Lifecycle Management / system validation activities
- Strong knowledge of common clinical and regulatory data standards, clinical operational data models and the ability to design or review data structures, mappings, and controls that are consistent and reusable.
- Experience leveraging automation, scripting, or digital solutions to streamline data-management activities and reduce manual effort.
- Knowledgeable drug discovery process, FDA regulations, GxP/ ICH (International Council for Harmonization) guidelines
- Ability to connect business outcomes to technical deliverables
Soft skills
- Communicate and negotiate effectively (oral/written) with technical and business partners and external service providers; adapt style to audience and able to translate technical topics for non-technical stakeholders.
- Lead day-to-day activities; drive issue triage to closure; coordinate stakeholders.
- Mentor junior team members on tools, checks, documentation quality, and best practices.
- Prioritize independently; escalate with context, impact, and recommendation.
- Deliver clear updates on status, decisions, and blockers; maintain decision logs.
Enterprise Leadership Skills
- Decision Making | Identify and understand problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; solve complex
- problems and apply knowledge of business challenges; able to weigh multiple options and implications
- Motivation & Inspiration | Communicate effectively, promote teamwork and open discussion, effectively communicate and engage / motivate teammates; inspire others toward higher levels of performance aligned with organization's Purpose and Strategic Framework
- Coaching & Development | Build self-insight, demonstrate awareness of own strengths and development needs as well as impact of own behavior on others; modify behavior based on self-awareness to improve impact, serve as a resource for colleagues; coach and guides others
- Qualifications & experience
- Non-Degree with a minimum of 8 years of experience in clinical data programming, data engineering, or related data-management/clinical operations functions.
- OR
- [Minimum preferred] Associate's Degree with a minimum of 7 years of experience in clinical data programming, data engineering, or related data-management/clinical operations functions.
- OR
- Bachelor’s Degree with a minimum of 5 years of experience in clinical data programming, data engineering, or related data-management/clinical operations functions.
- OR
- Advanced degree (Masters or Doctorate) with a minimum of 2 years of experience in clinical development and/or clinical data programming, data engineering, or related data-management/clinical operations functions.
Additional location(s) Compensation Information:
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 Improvements, Systems Development, System Validation, User Acceptance Testing (UAT), Vendor Management
Preferred Skills:
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/16/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.