Linda M. Talley

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.

Experience

1. Vice President, Clinical Data Management

   Ultragenyx

   Mar 2024 — Present · US

Education

• Ball State University

  Bachelor of Science, Computer Science

• Indiana University Indianapolis

  TQM- Certification, Total Quality Management

Skills

• Regulatory Submissions
• Leadership
• Drug Development
• Clinical Data Management
• Gcp
• Oracle Clinical
• Clinical Trial Management System (Ctms)
• Clinical Trials
• Biostatistics
• Regulatory Affairs
• U.s. Title 21 Cfr Part 11 Regulation
• Clinical Development
• Pharmacovigilance
• Validation
• CRO Management
• Oncology
• Protocol
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Industry
• Sop
• CRO
• Fda
• Gxp
• Vendor Management
• Cdisc
• Data Management
• Good Clinical Practice (Gcp)
• Clinical Research
• Cross-Functional Team Leadership
• Electronic Data Capture (Edc)
• Pharmaceutics
• Supervisory Skills
• Contract Management
• Computer System Validation
• Standard Operating Procedure (Sop)
• 21 Cfr Part 11
• Sdtm
• Edc
• Ctms