Study Manager - Bioanalysis
Less than 5 years experience • Staffing & Recruiting
*CRO or Pharma and GLP experience.
*LCMS/MS Method validation experience.
Local Relocation Assistance Available
The Study Manager is responsible for overseeing the conduct of method development, validation and analysis of samples in support of regulated pre-clinical and clinical bioanalytical studies.
Schedule the Bioanalysis team’s workload ensuring all studies are ready to start on time and are completed in the agreed timelines.
Ensure adequate supplies of consumables are maintained and reagents/supplies/blank matrices are ordered in a timely manner.
Ensure all work generated by the Bioanalysis team complies with regulatory requirements, SOPs, methods, validation/analytical plans and protocols, and the data is provided for review and approval in a timely manner.
Be trained in the role of Principle Investigator and Contributing Scientist including:
Trained in effective communication with the Sponsor and/or Study Director at all stages of the study from enquiry to study finalization.
Trained to effectively communicate with Analysts at all stages of the study including holding study start-up and study close out meetings.
Prepare and review authorized methods.
Trained in the preparation of study plan.
Review and interpret data upon completion of analysis including calibration standards, QC and incurred sample data.
Review study data files in a timely manner.
Prepare reports for QA review and address comments according to timelines.
Prepare reports for distribution to Sponsors and/or Study Director.
Trained in the study archiving procedure upon report finalization.
Work with Research Scientists to identify the sources of error.
Troubleshoot bioanalytical and instrumentation issues.
Write, revise and review laboratory SOPs as appropriate and drive process improvement.
*Master’s degree or above in a relevant scientific discipline plus a minimum of two years’ experience in a CRO or pharmaceutical environment or a Bachelor’s degree in a relevant scientific discipline plus a minimum of three years’ experience in a CRO or pharmaceutical environment.
Equal Opportunity Employer – Minorities / Females / Veterans / Individuals with Disabilities / Sexual Orientation / Gender Identity