Linda M. Talley

Vice President, Clinical Data Management @Ultragenyx

Indianapolis, IN, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Mar 2024 — Present

Vice President, Clinical Data Management @Ultragenyx

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EDUCATION

N/A

Ball State University

Bachelor of Science, Computer Science

N/A

Indiana University Indianapolis

TQM- Certification, Total Quality Management

SKILLS

Regulatory SubmissionsLeadershipDrug DevelopmentClinical Data ManagementGcpOracle ClinicalClinical Trial Management System (Ctms)Clinical TrialsBiostatisticsRegulatory AffairsU.s. Title 21 Cfr Part 11 RegulationClinical DevelopmentPharmacovigilanceValidationCRO ManagementOncologyProtocolU.s. Food and Drug Administration (Fda)Pharmaceutical IndustrySopCROFdaGxpVendor ManagementCdiscData ManagementGood Clinical Practice (Gcp)Clinical ResearchCross-Functional Team LeadershipElectronic Data Capture (Edc)PharmaceuticsSupervisory SkillsContract ManagementComputer System ValidationStandard Operating Procedure (Sop)21 Cfr Part 11SdtmEdcCtms

ABOUT LINDA M. TALLEY

Experienced Global Vice President with a demonstrated history of working over thirty (30) years in the Pharmeceutical and CRO industry. Highly skilled in Pharmaceutical Project Management, Clinical Data Management, Clincal Operations, Regulatory agency requirements for pharmaceutical submissions including U.S. Food and Drug Administration (FDA), Health Canada, MHRA(Medicines and Healthcare products Regulatory Agency), EMEA(European Medicines Evaluation Agency), MHLW(Minestry of Health Labor and Welfare), PMDA(Pharmaceutical and Medical Device agency, NMPA(National Medical Products Administration), etc, CDISC/CDASH/SDTM Standards, and CRO Partnership. Therapeutic experience in Oncology/ImmunoOncology, Neuroscience, Diabetes, Cardiovascular, Men and Womens’ Health, Autoimmune and Vaccines. Strong business development professional with a B.S. degree focused in Computer Science and Business from Ball State University.

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