Senior Manager, Technical SME Standards in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Technical SME Standards based in United States.

This role sits at the intersection of clinical data standards, technology, and innovation within a highly regulated biopharmaceutical environment. You will act as a key technical subject matter expert, enabling end-to-end data standardization across clinical development, from data collection through analysis and regulatory submission. The position plays a critical role in shaping and scaling automation, metadata management, and data lineage capabilities across global clinical systems. You will collaborate closely with engineering, IT, and clinical operations teams to design and implement advanced data workflows and digital tools. The environment is highly cross-functional, fast-evolving, and deeply focused on improving data quality, efficiency, and compliance. This is a strategic role where technical leadership directly accelerates clinical research outcomes and regulatory readiness.

• Serve as a technical liaison between the Data Standards organization, Clinical Data Engineering teams, CDS Systems, IT, and other cross-functional stakeholders to ensure alignment on data standards implementation and automation initiatives.
• Design and implement tools and frameworks that enable end-to-end data lineage, impact assessments, and traceability from data collection through analysis and reporting.
• Develop workflows and automation solutions supporting clinical data standardization, including SDTM and ADaM dataset generation and integration of normalized data layers.
• Oversee system operations for data standards platforms, including access management, system configuration, vendor coordination, and operational governance.
• Contribute to the development, testing, and documentation of analytical and automation tools supporting statistical outputs such as tables, figures, listings, and submission-ready datasets.
• Champion digital data flow strategies to reduce manual effort, improve data quality, and accelerate clinical trial processes through automation and scalable solutions.
• Stay current with evolving industry standards, regulatory expectations, and emerging technologies to continuously enhance data standards capabilities.

Requirements:

• 8+ years of experience with a BS in Biostatistics, Computer Science, or equivalent; or 4+ years with an MS; or 2+ years with a PhD in a related field.
• Strong experience in clinical trials across multiple phases and therapeutic areas, with hands-on involvement in clinical data pipelines and standards implementation.
• Deep understanding of clinical research frameworks, including CDISC standards, FDA and ICH guidelines, GCP, and regulatory submission requirements.
• Proven experience working with clinical data standards, metadata management, and end-to-end data workflows in a regulated environment.
• Proficiency in programming and data tools such as R or Python, with exposure to AI-assisted development and modern software engineering practices.
• Experience collaborating in cross-functional teams using GitHub or similar development environments.
• Strong analytical, problem-solving, communication, and stakeholder management skills, with the ability to manage multiple complex initiatives simultaneously.
• Demonstrated creativity and innovation mindset, with a proactive approach to improving data systems and processes.

Benefits:

• Competitive base salary ranging from approximately $153,935 to $219,120 depending on location and experience.
• Eligibility for annual discretionary bonus and long-term stock-based incentives (role dependent).
• Comprehensive health coverage including medical, dental, vision, and life insurance plans.
• Paid time off and additional company leave policies supporting work-life balance.
• Opportunity to work in a highly innovative, research-driven environment focused on advancing global healthcare.
• Exposure to cutting-edge clinical data technologies, automation initiatives, and AI-enabled development practices.
• Hybrid or remote flexibility depending on location and organizational needs.