Sruthi Lekha

Background

About Sruthi Lekha

Clinical Data Manager with years of experience in Clinical Data Management leading all data management expertise from Phases I to and various therapeutic areas of clinical trials including Neurology, Immunology and many different drug discovery projects.*Proficient in working with Phase I to Phase clinical trials using the EDC system.*I have a Sound knowledge of research study start-up, quality assurance, data review, data analysis, database clean-up, Lab Reconciliation, SAE Reconciliation and database finalization using clinical datamanagement systems.*Extensive knowledge of CRF design, Edit checks Engine, data cleaning and Manual query process, Lab Data Reconciliation and SAE Reconciliation. Developed Data Management Plans and made sure to maintain DMP throughout the life cycle of the study project.*Develop Case Report Forms (CRF), Develop Database (DB) clinical trial data specifications including eCRF design, annotating CRFs, database design, Edit check specification, and Query logics. User requirements and data validation.*Well-versed in Database QC, CRF tracking, Database Auditing, Data lock and Freeze.*Experience in managing databases, including but not limited to performing MedDRA and /or WHO coding. Extensive experience with vendor management to ensure data quality and timely delivery.*Good Knowledge of the CDISC, CDASH, and CFR 21 Part 11 guidelines.*Extensive experience in developing, reviewing, and maintaining Data Management Plans (DMP), DataTransfer Agreements (DTA), and CRF Completion guidelines (CCGs).*Analyzes and resolves discrepancies in data validation or other reports.*Proficient in performing User Acceptance Testing (UAT) including validating data entry screens.*Proficient with using Electronic Data capture systems like Medidata RAVE, Medidata Classic, Jarvis, Tenhilo and Edid check engine.*Strong knowledge and commitment to adherence to ICH-GCP, GCP, CDASH/CDISC, FDA and IRB.