Bioanalytical Principal Investigator - Small Molecule

Essential Functions:

• Serve as primary client contact for the bioanalytical segment of studies
• Review protocol and assure study is conducted in accordance with Protocol
• Document and report any deviations from the protocol to Study Director or Sponsor
• Review and approve Sample Analysis Plans
• Assure all experimental data is accurately recorded and verified
• Assure corrective action is taken and documented when necessary
• Review and approve all project-related QA audits
• Approve and document any bioanalytical deviations
• Review and approve all bioanalytical reports
• Assure all study personnel have adequate training, education and experience to perform required study functions
• Conduct impact analysis of bioanalytical deviations
• Oversight of Event Investigation reports

Requirements:

• Minimum of a Bachelor's degree or equivalent in a science-related field with 5 or more years of industry experience preferred
• 5 or more years of previous laboratory and/or regulated bioanalysis knowledge preferred
• Proficiency with computers 
• Excellent oral and written skills 

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