Radhika HV

An enthusiastic, skilled, and reliable Senior Clinical Data Manager with overall 10 years of experience in Clinical Data Management. Skilled on various Start up, Conduct, and Closure activities across phases in multiple trials. Proficient in scheduling Project meetings, document preparation, and archival of study documents, with a strong focus on safety, efficiency and accuracy of the patient data and good understanding of FDA and GCDMP and ICH GCP guidelines, seeking a position in a highly reputed and professional Clinical research work environment and apply my best data management practices and exploration to work for individual growth and overall progress of the organization.

• Review of protocol thoroughly to provide inputs/clarifications/discussions with the clinical team if needed and involve in the finalization of protocol.
• Conduct of edit checks UAT and document the findings in Technical Designer Checklist. Coordinate with the TD to fix the issues.
• Performed Dataset Validation in accordance with SDTM.
• Creation of DMP.
• Creation of Study Data Reviewer’s Guide.
• Performed UAT Data entry for Frontend and Backend checks and validated the outputs provided by the Programmers and coordinated effectively to fix issues
• Review clinical trials data in accordance with Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data and run ancillary programs (e.g. special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications, in the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions, and in the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities.
• Performed Testing of functionality of UAT Frontend Checks on HPALM
• Develop various documents during the set-up phase of the study (DMP, DB Specification, Edit check specification, DTS, eCRF completion guidelines)
• Perform DB build tasks by creating specifications for Database and Edit Check.
• Create external Data Transfer Agreement for third party vendors.

• Knowledge in creation of CDISC compliance SDTM Standard (3.1.3) and (3.2) datasets from raw data.
• Good understanding in CDISC SDTM models.
• Knowledge in using SAS procedures like PROC REPORT, PROC SORT, PROC TRANSPOSE, PROC FREQ, PROC MEANS, PROC PRINT and PROC SQL, COMPBL, SUBSTR, SCAN, PUT, INPUT, INDEX, CAT, COUNT, INTCK/INTNX AND TRANSLATE/ TRANWRD, ADaM, TLF
• Plan/execute Postproduction/Migration for the study (if any).
• Share project review metrics on scheduled basis to the team, update the study information
• Generate, resolve and track queries to address trends identified during query review and data review activities and apply proper modification / correction to the database.
• Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third-party vendor data (eCRF, eDiary, specialty laboratory, etc.) and perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation.
• Accurately perform SAE Reconciliation, PK reconciliation, Lab reconciliation, ECG, IWRS, ECOA, in accordance with all applicable procedures.
• Attend sponsor meetings provide study metrics and discuss any roadblocks
• Coordinate with external data vendors for any escalations related to any vendor data
• Validation of the listing outputs provided by the Programmers and coordinating effectively with the programmers to fix issues
• Support Clean Patient Group delivery along with Clinical Data Management staff.
• Update study documents as needed during the conduct of the study
• Provide Data Health Metrics to Data Management Lead as requested.
• Protocol amendment review and PK time point review
• PD Review on monthly basis and performing DM review for various subject status.
• Migration/PPC related activities. Creation of Change order log and Edit check specification document as per sponsor requirement.

• Review DB lock/interim timelines and plan and ensure project team is meeting the deliverables as per the client expectations and timelines
• Support Data Management Lead in planning and execution of database lock activities
• Perform final database lock activities like subject review, freezing and locking.
• Perform post lock activities and archival activities, as needed.
• Lead DM including responsibility for the development of the project documentation, system set-up, data validation procedures and processes assigned to more junior staff. Assist with all data management activities including database lock according to client quality expectations & project timelines.
• Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures.
• Handled ad-hoc reporting request and provided data for trending/analysis for strategic meetings
• Creation of DHR.
• Preparing various weekly and monthly metrics (CPT, Lab matrix reports, out of window listings)

• Filing of appropriate documents in eTMF as per eTMF master plan.
• Front-end test case creation (Clinical, Dynamic, Derivative, SAE mail alert) in UAT Testing.
• Back-end test cases creation and data entry (Vendor and Non-vendor)
• DVR and DVS Review – Review DVR/DVS document