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
- Implement solutions for RBQM, data review and cleaning, as defined in data quality plans and enable the detection of data quality insights.
- Manage configuration of system to support data ingestion, transformation and provisioning required standard and study specific outputs ( e.g. KRIs, QTLs ). Use SAS or Python programming skills while developing required outputs.
- Troubleshoot and resolve routine technical issues related to build, transformations, reports, and visualizations.
- Support post‑production changes by performing impact analysis and helping implement approved change requests.
- Participate in key study milestones such as database go‑lives, dry runs, interim snapshots, and database locks.
- Support system upgrades and validations, including impact assessments and execution of validation activities.
- Develop and maintain study documentation, ensuring accuracy, completeness, and compliance with standards.
- Collaborate with internal teams and vendors, act as subject matter expertise while continuously sharing knowledge within the team.
Essential Requirement
- Minimum 6 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
Clinical Trials, Computer Programming, Data Analysis, Programming Languages, Reporting (Inactive), Statistical Analysis
