Dawn Kaminski

About Dawn Kaminski

I have over 25 years of experience in the pharmaceutical industry. I have worked within every level of clinical data management, from Data Coordinator to Senior Director where I participated in or had oversight for more than 250 clinical trials.During my time in the industry, I have provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. I am an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (20••••21). I serve as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. I am into my 2nd term on the SCDM Board of Trustees.I currently hold the position of Vice President, BD Operations where I am responsible for the growth and strategic expansion of the BD operations group.

Experience

1. Vice President, Bd Operations

   eClinical Solutions

   Jun 2022 — Present

Education

• Chestnut Hill College

  Bachelor of Science, Biology

  1993 — 1997

Skills

• Clinical Data Management
• Edc
• Cdisc
• CRO
• 21 Cfr Part 11
• Clinical Trials
• Clinical Development
• Gcp
• Oncology
• Ctms
• Product Management
• Drug Development
• Quality Assurance
• Ich-Gcp
• Therapeutic Areas
• Computer System Validation
• Pharmaceutical Industry
• Regulatory Submissions
• Sop
• Fda
• Oracle Clinical
• Regulatory Affairs
• Validation
• Pharmacovigilance
• Crf Design
• Data Management
• Good Clinical Practice (Gcp)
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• CRO Management
• Electronic Data Capture (Edc)