SummaryThe Senior Manager, Clinical Informatics is responsible for leading the design, implementation, and continuous improvement of clinical data flow, integration, analytics, visualization, and reporting capabilities across the clinical development portfolio. The role oversees the configuration, testing, and lifecycle management of data visualization software, patient randomization and drug supply logistics (IRT), and eCOA systems. The role partners with Clinical Trial Teams, Data Management, Biostatistics, Clinical Drug Supply and other functional stakeholders to develop scalable, compliant, and data-driven solutions that support clinical trial oversight, decision-making, operational excellence, and data quality within a validated GxP environment.
Your Role:- Partner with Clinical Trial Teams and other functional stakeholders to define and implement clinical data flow, integration, visualization, and analytics strategies across the clinical development portfolio
- Lead development and maintenance of trial-related IRT/ eCOA systems and related processes. Provide oversight to IRT/ eCOA vendors to ensure alignment with protocol requirements and study objectives
- Translate business requirements into scalable reporting, dashboard, analytics, trial supply management and data visualization solutions that support trial oversight, risk management, operational performance, and decision-making
- Drive standardization of clinical data flows, clinical data system integrations, business rules, reporting processes, and analytics frameworks to improve consistency, efficiency, scalability, and data governance across studies and programs
- Lead the implementation, integration, enhancement, and lifecycle management of clinical systems, analytics platforms, and data visualization solutions supporting clinical development activities
- Provide oversight of clinical systems vendors, technology partners, system configurations and data integrations to ensure solutions meet business requirements, quality standards, timelines, and regulatory expectations
- Drive adoption of automation, advanced analytics, artificial intelligence, machine learning, and cloud-based technologies to enhance operational efficiency, data accessibility, and decision-making within a validated GxP environment
- Ensure clinical systems, analytics platforms, and data integration processes comply with regulatory requirements, computerized system validation standards, data governance principles, and inspection readiness expectations
- Support audits, inspections, and health authority interactions related to clinical systems, analytics platforms, and clinical data flows
- Develop user training, guidance, and support programs and contribute to continuous improvement initiatives focused on data interoperability, automation, reporting capabilities, and operational excellence
What You Bring:- 7+ years of experience in Clinical Informatics, Clinical Data Management, Statistical Programming, Clinical Systems, or related functions within the biotechnology, pharmaceutical, or CRO industry
- Experience implementing clinical data flow, integration, reporting, visualization, and analytics solutions in a regulated environment
- Experience supporting global clinical development programs and cross-functional clinical teams
- Experience managing clinical systems (incl. IRT/ eCOA) configurations and implementations, enhancements, integrations, and technology vendors; experience leading User Acceptance Testing (UAT)
- Experience supporting computerized system validation (CSV/CSA) activities and regulated GxP systems
- Experience managing external data integrations from CROs, laboratories, imaging vendors, and other external providers
- Experience supporting audits, inspections, and inspection-readiness activities
- Experience with cloud-based technologies, automation initiatives, and digital transformation programs
- Strong knowledge of clinical trial processes, clinical data flows, and data governance principles
- Strong knowledge of industry data standards, including CDISC, CDASH, SDTM, ADaM, OMOP, BRIDG, and related frameworks
- Strong knowledge of ICH-GCP, FDA regulations, EU Clinical Trial Regulation (CTR), computerized system validation requirements, and other applicable regulatory requirements
- Expertise in data visualization, analytics, dashboard development, system configuration and reporting best practices
- Strong understanding of SaaS, cloud, data integration, interoperability, artificial intelligence, and machine learning technologies in a regulated environment
- Proficiency with analytics and visualization platforms such as Spotfire, Elluminate, Power BI, or equivalent technologies
- Strong understanding of configurable clinical systems including EDC, CTMS, eTMF, IRT, eCOA, and related clinical technologies
- Strong project management and vendor management capabilities
- Strong analytical thinking, problem-solving, and decision-making skills
- Ability to translate complex business requirements into scalable technical solutions
- Excellent stakeholder management, communication, and cross-functional collaboration skills
- Ability to manage multiple priorities and projects in a fast-paced environment
#LI-Hybrid
Salary range
$144,800-$217,200 USD
