Job Description

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.

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

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis