Ranadhir Reddy Punreddy

Lead end-to-end Clinical Data Management activities across Phase I–III studies, ensuring high-quality, audit-ready data delivery aligned with timelines Manage key milestones including Go-Live, Interim Analysis, and Database Lock (DBL) while maintaining strict oversight of data quality and database integrity Perform comprehensive quality checks to ensure database build aligns with protocol specifications, study requirements, and regulatory standards Implement risk-based data review and monitoring strategies to proactively identify discrepancies and maintain compliance with GCDMP Drive data cleaning and review activities including listings review, J-review reports, discrepancy management, and timely query resolution with sites Support database setup activities including CRF design review, edit checks, annotations, and User Acceptance Testing (UAT) Contribute to Onscreen Review Meetings (OSRM) and provide inputs to ensure database readiness and SDTM-aligned CRF annotations Review and approve key study documents including Mock CRF, Edit Check Specifications (ECS), Study Specifications (SPS), Data Transfer Specifications (DTS), eCRF Completion Guidelines (eCCG), and Data Handling Plans (DHP) Coordinate and lead Data Review Team (DRT) and Study Status meetings to ensure CRO performance and on-time, high-quality deliverables Collaborate with CRAs, site monitors, CRO teams, and cross-functional stakeholders to resolve data issues and track missing or discrepant data Manage post-production database changes, conduct impact assessments, and perform UAT for post-production changes (PPC) Ensure CRO adherence to SOPs, study protocols, and global regulatory standards including ICH-GCP, FDA, EMA, and 21 CFR Part 11 Identify risks in data management processes, implement mitigation plans, and track KPIs to improve CRO performance and study efficiency

Executed data cleaning tasks encompassing query management, reconciliations, manual review, and related activities. Actively engaged in both internal and external team meetings, fostering effective communication. Addressed data discrepancies and associated issues by collaborating with relevant stakeholders. Provided support to the lead data manager in various study-related tasks. Generated study-specific reports, ad hoc reports, and metrics to monitor study progress. Coordinated all data management activities for the assigned studies and ensured equitable distribution of tasks among the team. Reconcile Serious Adverse Events (SAEs) and vendor data (ePRO, IVRS, lab, PK, imaging) to ensure data consistency and alignment with protocol requirements. Developed essential project documents, including the Data Management Plan (DMP), Case Report Form (CRF) completion guidelines (CCGs), and Data Transfer Agreements (DTA). Assisted in database upgrades/migrations, including the performance of User Acceptance Tests. Liaised with monitoring, medical coding, database programming, and statistical programming teams to ensure the smooth operation of studies. Adhered rigorously to Standard Operating Procedures (SOPs), International Conference on Harmonization - Good Clinical Practice (ICH GCP) guidelines, protocol requirements, and standard industry guidelines. Reviewed and assessed eCRF screen design and written data management plans for the assigned studies, where applicable. Contributed to Database Lock (DBL) activities, including planning, and executing listing reviews and identifying any issues that may risk the timelines of DBL.

Engaged in comprehensive end-to-end clinical data management activities, spanning from study initiation to database lock. Developed and conducted quality checks on Edit Check specifications and Report Writing specifications. Assisted in the periodic review of study files to ensure accuracy and completeness. Carried out critical tasks, including User Acceptance Testing, Query Management, and medical coding. Acted as a backup for the data team lead, overseeing day-to-day Clinical Data Management (CDM) operations. Maintained essential project documents, such as the Data Management Plan (DMP), Data Validation Documents, Case Report Form (CRF) completion guidelines, and Data Transfer Agreements. Effectively communicated study metrics to the team, vendors, and key stakeholders, including clinical site administrators. Proficiently managed discrepancy resolution, encompassing both automatic and manual processes. Was responsible for performing all assigned DM activities by Lead DM.