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I am a leader who believes within my team, empowering them to succeed, and in creating leaders. I am a good listener and I believe in providing all the tools my team needs to succeed. I have over 15 years of Data Management experience in various therapeutic areas. For the last 10 years, I am responsible for overseeing various teams within Data Management globally from study start-up to close out, of Phase 1-IV trials. I am actively involved in writing SOP/Working Instructions for different processes within Data Management. I am part of cross-functional teams championing different initiatives. I am part of a core team involved in MHRA/FDA/Health Inspections and strategic partnerships with other companies. I have experience in setting up new teams, along with processes for the team to follow. I am involved in hiring, training, and oversight. SKILLS Therapeutic Areas: Oncology, Immunology, Infectious disease, Cardiovascular Medidata Rave, Inform and InSpire, Endpoint, 4G, Suvoda, Clintrial 4.3, Jreview, SPSS, Oracle Clinical, Cross-Functional team involvement, study Build, UAT, Query Management, Vendor Management, Safety, and Lab Data Reconciliation, Data Validation, DataBase Lock, ad hoc reports, Knowledge of Biomarker, Pharmacology, Managing CRO, External Vendors, Budgets, Projections, Costing, Imaging review, RECIST 1.1, irRECIST, Team Management, Decision maker, Data review, Training, Team player, Team builder, Team coach, digital transformation, presentations, people manager, mentor, Trustworthy, Collaborative, passionate, CDISC/CDASH, SDTM, MedDRA, WHO Drug Dictionary, GCP/ICH and 21 CFR part 1
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