Shawn Charles

FAQ About Shawn Charles

• What is Shawn Charles's address?

  Shawn Charles is located at
  Sparta, New Jersey, United States

• What is Shawn Charles's job title?

  Shawn Charles is a
  Clinical Bioanalytical Scientific Monitor at ICON plc (Merck KGAa) - both a scientific and operational role within the Biosample Operations group in Global Development to provide scientific and technical oversight, as well as enabling operational processes and the delivery of clinical bioanalytical data from Contract Research Organization's (CRO) to support NBE/NCE for PK, ADA & ADC clinical development programs. As an bioanalytical operations analyst, partners with the functional groups of clinical trial business and other key stakeholders across global clinical operations. Supports vendor business operations, strategic financial controls and resource management. Develops organizational tools and mechanisms relevant to business operations and vendor management. Bioanalytical Outsourcing Manager, supports the externalization and operationalization of small molecules, biomarkers and bioanalytical activities that are part of clinical trial programs Work collaboratively with the CROs, assure that all studies are managed in respect to timelines, budget and quality deliverables by GCP and GLP guidelines. Interfacing with Clinical Trial Operational Managers, Data Managers and sample management to ensure the specifics to the logistics of sample support Bioanalytical Chemist working in Pre-Clinical Drug Safety and Metabolism – Pharmacokinetics: managed multiple projects and delivered data on time in support of drug discovery, nonclinical, clinical and toxicology studies. Studies performed under GCP/GLP guidelines, Interact with regulatory agencies, QC/QA to ensure compliance with internal SOP's and GLP regulations. Bioanalytical assay chromatographic and extraction methods development, validation and sample analysis, with quantitation by HPLC and mass spectrometry (LC-MS/MS) to support pharmacokinetic, toxicokinetic, clinical efficacy and/or human food safety studies in a GLP environment. Developed universal laboratory robotic instrumentation software program for liquid handler (Hamilton) to increase precision, accuracy and productivity by 50% for entire department. Implemented an automated report writing tool to extract data from Watson LIMS to Microsoft Word, increased efficiency of writing and tabulating analytical reports by 75%. Responsible for designing, and support of pharmacokinetic, metabolism (ADME), and residue programs to support registration of small molecule pharmaceuticals for studies in-house and with external providers. Icon Strategic Solutions

• What industry does Shawn Charles currently work in?

  Shawn Charles currently works in the
  Icon Strategic Solutions

• What is Shawn Charles's area of expertise?

  Shawn Charles specializes in
  Clinical Bioanalytical Scientific Monitor at ICON plc (Merck KGAa) - both a scientific and operational role within the Biosample Operations group in Global Development to provide scientific and technical oversight, as well as enabling operational processes and the delivery of clinical bioanalytical data from Contract Research Organization's (CRO) to support NBE/NCE for PK, ADA & ADC clinical development programs. As an bioanalytical operations analyst, partners with the functional groups of clinical trial business and other key stakeholders across global clinical operations. Supports vendor business operations, strategic financial controls and resource management. Develops organizational tools and mechanisms relevant to business operations and vendor management. Bioanalytical Outsourcing Manager, supports the externalization and operationalization of small molecules, biomarkers and bioanalytical activities that are part of clinical trial programs Work collaboratively with the CROs, assure that all studies are managed in respect to timelines, budget and quality deliverables by GCP and GLP guidelines. Interfacing with Clinical Trial Operational Managers, Data Managers and sample management to ensure the specifics to the logistics of sample support Bioanalytical Chemist working in Pre-Clinical Drug Safety and Metabolism – Pharmacokinetics: managed multiple projects and delivered data on time in support of drug discovery, nonclinical, clinical and toxicology studies. Studies performed under GCP/GLP guidelines, Interact with regulatory agencies, QC/QA to ensure compliance with internal SOP's and GLP regulations. Bioanalytical assay chromatographic and extraction methods development, validation and sample analysis, with quantitation by HPLC and mass spectrometry (LC-MS/MS) to support pharmacokinetic, toxicokinetic, clinical efficacy and/or human food safety studies in a GLP environment. Developed universal laboratory robotic instrumentation software program for liquid handler (Hamilton) to increase precision, accuracy and productivity by 50% for entire department. Implemented an automated report writing tool to extract data from Watson LIMS to Microsoft Word, increased efficiency of writing and tabulating analytical reports by 75%. Responsible for designing, and support of pharmacokinetic, metabolism (ADME), and residue programs to support registration of small molecule pharmaceuticals for studies in-house and with external providers.

• Which languages does Shawn Charles speak? 

  Shawn Charles speaks the following languages:
  No languages available.

• Which industries has Shawn Charles previously worked in?   

  Shawn Charles has prior experience in the following industries:
  Bristol Myers Squibb , Sanofi , Celgene , Merck Research Laboratories , Intervetschering Plough Animal Health

• What is Shawn Charles’s work experience?  

  Shawn Charles has the following professional experience:
  Icon Strategic Solutions , Bristol Myers Squibb , Sanofi , Celgene , Merck Research Laboratories , Intervetschering Plough Animal Health .

• How can I find Shawn Charles on LinkedIn?  

  You can view Shawn Charles’s
  LinkedIn profile at LinkedIn URL.

• What are Shawn Charles’s work email addresses?  

  Shawn Charles’s work email addresses are
  [email protected] .

• What company does Shawn Charles work for?  

  Shawn Charles works at
  Icon Strategic Solutions