Principal Clinical Programmer

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 Life Science related industry
• Strong knowledge of any programming languages (SAS, Python, R etc.)
• Knowledge of Data Review and/or Business Intelligence tools (such as Central monitoring platform)
• Understanding of clinical data management systems and/or relational databases as applied to clinical trials
• Ability to translate technical concepts for non- technical users in the areas of central monitoring platform design and visualization development
• Strong verbal and written communication skills to work with our global partners and customers
• Understanding of Drug Development Process, ICH- GCP, CDISC standards and Health Authority guidelines and regulations