Role & responsibilities

- Owning the design and delivery of a centralized clinical reporting platform consolidating EDC listings, exception reports, and vendor reconciliation outputs
- Building and maintaining Clean Patient Tracker applications providing real-time access to CRF completion, visit status, data queries, freeze/lock status, and PI signature status
- Developing executive-level dashboards highlighting portfolio-wide KPIs such as query aging, protocol deviations, data entry lag, and study completion achievements
- Partnering with Data Management Reporting teams and external vendor delivery teams to establish structured data ingestion pipelines for EDC and reconciliation reports
- Collaborating with Clinical Sciences, Biostatistics, Safety, and Precision Medicine teams to develop validated self-service analytical tools and reporting applications
- Designing and implementing data visualization standards, UX/UI guidelines, and reporting procedures for non-technical stakeholders
- Building curated analytical datasets and semantic layers connected to clinical data lakes and vendor reconciliation feeds
- Running the full reporting lifecycle including requirements gathering, UX wireframing, development, validation, UAT coordination, and production deployment
- Driving automation across routine reporting workflows including scheduled data ingestion, reconciliation report generation, and alert-based notifications
- Supporting GCP compliance, inspection readiness, report governance, version control, and audit trail management
- Driving adoption of reporting tools through stakeholder engagement, training,



and change management initiatives
- Serving as an SME for clinical data reporting, embedded analytics, and emerging visualization technologies

This Role May Be For You If You Have:

- Demonstrable experience in Clinical Data Management, clinical trial reporting, analytics, or reporting platform development
- Hands-on experience with Medidata Rave EDC including query management workflows and dataset structures
- Solid understanding of CDISC CDASH/SDTM standards and GxP/CSV validation principles
- Experience developing reporting applications using Python frameworks such as Dash, Streamlit, or Flask
- Demonstrable experience with Power BI, Tableau, SQL, and analytical dataset development
- Experience working with clinical data sources, clinical metrics, and external vendor reconciliation outputs
- Strong UX/UI design sensibility for building intuitive reporting tools for non-technical users
- Excellent stakeholder management, communication, and presentation skills
- Solid analytical thinking and problem-solving capabilities
- Ability to work optimally in a fast-paced, matrixed, and multi-functional environment

To Be Considered For This Role, You Must Have:

- 8+ years of experience in Clinical Data Management or clinical trial operations
- Minimum 3+ years focused on clinical data reporting, analytics, or reporting tool development
- Experience with clinical reporting applications, dashboards, and data visualization tools
- Bachelors or Master’s degree in Computer Science, Data Science, Bioinformatics, or a related field
- Advanced degree (MBA/MS) preferred

📌 Senior Manager - Full Stack Developer- Clinical Data Operation (Hyderabad)
🏢 Randstad
📍 Hyderabad