Saideepthi Mididoddi

6+ years of working experience and expertise in Clinical Research, Data Management, Data Validation, and Data Processing in OC, inform and Rave platform. Proven ability to organize and execute skills whenever required and lives up to the expectation of the organization. Experienced in working with different phases of Clinical Trial from Phase I, II & III. Extensive experience in designing eCRF Specifications, edit checks specifications, User acceptance testing (UAT), Lab Reconciliation, external vendor data reconciliation, Data Cleaning, and discrepancy management. Proficient in working with both Paper & EDC trials and understanding of industry standards including ICH-GCP guidelines, GCDMP, and 21 CFR Part 11. Worked comprehensively on a wide range of EDC Databases –Medidata Rave and Inform to perform Query Management and other data management tasks. Developed Data Management Plans (DMP/DHP). Proficient in Team management, Vendor Management, Client Interaction, and communication within different departments of the Clinical research domain. Experienced working with cross-functional teams (Biostatistics, Programmers, Clinical Operations, Safety team, Clinical & DM CROs, Labs) regarding the project related issues. Mentored Junior DM staff, prioritized their assigned tasks, and helped with the completion of their tasks. A quick learner with an eye for detail and always emerged to be an excellent team player with strong leadership skills. Good communication, written, and Verbal skills. Well-organized, high attention to detail and degree of accuracy, worked in collaborative environment, proactive and proficient in Multitasking. Have good experience in Medidata ALS UAT and Edit Checks creation while performing UAT. UAT of Screens and Edit checks for study Go-Live. UAT for study migration due to database updates/protocol amendment. Publish edits UAT. Served as Subject Matter Expert for Access Management. Creation and updates to CRF completion guidelines. Performed DM quality review check. Worked on Medical query review and action with quality and timely manner. Provide metrics and/or status updates of the study to the clinical team. Attending TC’s for assigned studies with the study team to resolve the issues. Good knowledge of CDISC, CDASH and SDTM.

• NIDA – Good Clinical Practice
• EACCME – Adverse Drug reactions: reporting makes medicines safer (MHRA UK)