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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Skills Required
- Bachelor's degree or equivalent in a science-related field
- 5 or more years of industry experience
- 5 or more years of laboratory and/or regulated bioanalysis knowledge
- Proficiency with computers
- Excellent oral and written communication skills
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
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