Company
Pharmaceutical
PrincipalClinicalProgrammer
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“Principal Clinical Programmer. Skills: RBQM platform configuration, Data-driven solutions, Central monitoring dashboards. Configure and manage Central Monitoring Platform. Translate study requirements into data-driven solutions”
What You'll Achieve.
Ensure data quality; Ensure overall trial success
Industry & Context.
Root cause analysis; Troubleshoot technical issues
What They're Looking For.
Must Have
Minimum 9 years of experience in clinical review and report programming, business analytics and/or clinical trial setup, Knowledge of any programming languages (SAS, Python, R etc.), Knowledge of Data Review and/or Business Intelligence tools, Understanding of clinical data management systems and/or relational databases as applied to clinical trials, Ability to translate technical concepts for non-technical users, Verbal and written communication skills, Understanding of Drug Development Process, ICH- GCP, CDISC standards and Health Authority guidelines and regulations
Nice to Have
PhD preferred, Specific ML framework experience, Cloud platform certs
What You'll Do.
Configure and manage Central Monitoring Platform
Translate study requirements into data-driven solutions
Develop and maintain Key Risk Indicators (KRIs)
Develop and maintain Quality Tolerance Limits (QTLs)
Develop and maintain Data Quality Analytics/Statistical Monitoring tests
Build central monitoring dashboards
Build central monitoring reports
Ensure accurate data ingestion
Ensure data harmonization
Ensure data visualization
Lead RBQM platform configuration
Develop specifications basis study documentation
Develop specifications basis inputs from study teams
Configure system to support data ingestion
Configure system to support data transformation
Configure system to support provisioning standard outputs
Configure system to support provisioning study specific outputs
Troubleshoot and resolve technical issues related to RBQM
Support impact analysis of post-production change requests
Support delivery of post-production change requests
Identify quality issues
Identify quality trends
Perform root cause analysis
Recommend preventive actions
Represent Clinical Dataflow & Insights team in key
Represent Clinical Dataflow & Insights team in discussions
Serve as a Subject Matter Expert (SME) for
Provide expert guidance on best practices across studies
Provide expert guidance on best practices across platforms
Translate complex business needs into required solutions
Translate complex business needs into required reports
Translate complex business needs into required Visualizations
How You'll Work.
Team & Collaboration
Cross-functional collaborator; Work with Central Monitors; Work with study teams; Work with stakeholders
Communication Scope
Verbal communication; Written communication
Full Job Description
**Job Description Summary** Responsible for configuring and managing the Central Monitoring Platform by translating study requirements into data-driven solutions, while developing and maintaining Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and Data Quality Analytics/Statistical Monitoring tests to enable proactive risk detection. The role also involves building central monitoring dashboards and reports with accurate data ingestion, harmonization, and visualization for effective study oversight, and acting as a technical, cross-functional collaborator by working closely with Central Monitors, study teams, and stakeholders to ensure data quality and overall trial success. **Job Description** **Key Responsibilities:** **RBQM Solution Development** * Leads RBQM platform configuration, develop specifications basis study documentation and inputs from study teams * Leads the configuration of system to support data ingestion, transformation and provisioning required standard and study specific outputs ( e.g. KRIs, QTLs ) **Technical Support & Maintenance** * Troubleshoot and resolve technical issues related to RBQM platform * Support the impact analysis and delivery of post-production change requests. * Identify quality issues & trends, perform root cause analysis, and recommend preventive actions. * Represent Clinical Dataflow & Insights team in key study milestones /discussions (database go-lives, snapshots, dry runs, interim analysis, DB locks). **People, Project Engagement & Quality Management** * Serve as a Subject Matter Expert (SME) for Clinical Dataflow & Insights, providing expert guidance on best practices across studies and platforms. * Translate complex business needs into required solutions/ reports/ Visualizations. * Support Audits and Inspections. **Essential Requirements** * Minimum 9 years of experience in clinical review and report programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Li
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