Monitoring Oversight System

Client is modernizing its clinical oversight by replacing a fragmented legacy system with a unified, APEX-based Management Oversight System module. This project addresses critical risks and oversight gaps by digitizing and standardizing the processes used to evaluate study team (CRA, CTM) effectiveness.

Key use cases include the introduction of Sign-off-Visits (SoV), Monitoring Evaluation Visit, Training Visit, Key Quality Indicators (KQI), Monitoring Visit Reports (MVR), and TMF Assessments, and SCAN Action Plans to ensure better compliance with Good Clinical Practices.

This streamlined data environment allows managers to move away from manual tasks and focus on trending analysis across all studies and regions. Ultimately, the new platform reduces financial overburn from re-monitoring while significantly improving audit readiness and transparency.

Key responsibilities include:

1. Design interactive, responsive web applications using Oracle APEX components like interactive grids, reports, and forms.

2. Develop and maintain database objects (tables, functions, packages) using SQL and PL/SQL.

3. Fix bugs, troubleshoot performance issues

4. Work with business analysts, stakeholders, and DBAs to translate business requirements into technical specs, while documenting code and system designs.

The application supports both automated and manual questionnaire creation, with configuration driven through an admin panel. For each work location, administrators can define questionnaire frequency, assign specific questionnaire types, and control availability.

Questionnaires are generated automatically based on configured frequency (monthly, quarterly, semi-annual, annual, and ones for 2 yeas for specific cases), ensuring consistent and timely data collection.

Each questionnaire includes three main sections:
• List View – overview of all questionnaires with status tracking
• Applicability – configuration visibility and availability control per location
• Summary – reporting of completed questionnaires

The system enforces strict data integrity rules:
• Questionnaire creation is restricted if not properly configured in the admin panel
• Deletion is not allowed — instead, a soft delete mechanism is implemented, requiring a mandatory reason and changing the status to “Not Completed”

Questionnaire forms are dynamic and vary in structure, typically including:
• General information section
• Recommended Improvement Actions (RIA), where actions are categorized, linked to specific questions, and tracked with their own statuses

Owned end-to-end Oracle APEX development, including UI/UX implementation, business logic, and database layer, working in collaboration with  backend and frontend developers.