Kimberly Williams

About Kimberly Williams

My career is a solid balance of Information Technology, coupled with critical in-depth business knowledge and understanding of Clinical Research and Development and clinical systems. I am flexible and versed in working in fast paced multi-layered environments. I understand not only the technical needs, but the business needs to support clinical study teams, including global Phase I – IV clinical trials. I effectively lead cross-functional teams supporting multiple therapeutic areas with the development and implementation of clinical systems (IRT, IVRS, EDC, ETMF, CTMS). I provide organizations not only with, my technical expertise, but an in-depth understanding of the Drug Development Process and federal regulated systems adhering to GxP, Federal Regulations and ICH Guidelines.When I am not on the job, I love listening to live music, bowling and spending time with family, our dog Maxie, and friends.

Experience

1. Information Systems Director (Consultant)

   Clinical Research Advancement

   Jun 2022 — Present · SC, US

   Operational oversight of the planning, implementation, and close-out of the Rare Disease clinical trial pipeline. Ensure clinical trial execution is in compliance with ICH/GCP guidelines and regulations.• Development and management of overall study budgets, clinical study timelines, metrics, and clinical trial risk assessment identification. • Manage study start-up, initiation, and close-out tasks including the development and review of Clinical Protocols, ICFs, CRFs, and SOPs. Review and finalization of monitoring reports and tracking of action items to completion.• Oversee the selection and qualification of clinical trial sites and Vendors, including the scope of work development, change order review, and oversight. Contributes to the development of RFPs and participates in the selection of CROs and vendors.• Manage contractual activities of CROs, central labs, imaging vendors, and specialty labs including outlining partner roles and responsibilities and technical milestones triggering payments. • Review and approve vendor activities and clinical invoices against approved scope of work and budgets; evaluate and approve vendor change orders.• Manage the Unblinded Clinical Drug Supply while providing clinical oversight and quality assessment for Integrated Response Technology (IRT) Vendor management. Successfully configure the drug supply network, develop replenishment strategies, and review sourcing options with the Clinical Supply team. Manage the inventory allocation and expiration dates while resolving supply-related issue

Education

• Indiana State University

  Masters of Business Administration, Marketing and eBusiness

  1998 — 2000

• Renaissance High School

  H.S. Diploma, High School Diploma

  1985 — 1989

• Michigan State University

  Bachelors of Science, Social Science; Information Systems

  1989 — 1994

• University of Phoenix

  M.A., Organizational Management

  2003 — 2006