Study Monitor

3 weeks ago

Thousand Oaks, United States Meet Full time

I am partnered with an exciting Biotech company out of Thousand Oaks, CA looking to grow their team with a Non-Clinical Study Monitor / Project Manager, In Vivo. They are ideally looking for someone with a research / lab background who moved into Project Management / Coordination. This person would be the liaison / help manage the relationship between the company and the CRO's they partner with.


Your responsibilities include, but are not limited to:


  • Establishment of, and adherence to, non-clinical study timelines, monitoring of study conduct at the CRO via communication with the Study Director and/or onsite observation
  • Real time communication with R&D team throughout study planning, execution, and reporting
  • Support future growth activities e.g. laboratory capabilities and in-house nonclinical study conduct.


Study Implementation and Conduct


Manage study achievements and metrics to ensure delivery to corporate milestones.

  • Potential representative to visit CROs during the study to ensure technical capabilities are adequate and procedures match the protocol.
  • Interact with CROs for any study-related issues. Make the initial determination of the impact of the issue on the integrity of the study.


Study Design and Protocol Development


  • Resolve any concerns with CROs regarding specific components of study protocols; whether scientific or logistical.


Data Review and Report Writing/Review


  • Coordinate and monitor the internal review of study data to assure compliance with study timelines.
  • Compile all report comments and assure they are conveyed to the Study Director at the CRO


Your profile:


  • Bachelor’s degree in biology, Animal Sciences, Toxicology or a related field with 3 or more years of experience in relevant industry setting
  • Expertise in management of nonclinical safety assessment study conduct, including the fundamentals of Good Laboratory Practices (GLP) and data interpretation of nonclinical studies
  • Experience in animal husbandry/in-vivo study conduct within Toxicology strongly preferred
  • Project management experience/PMP certification strongly preferred
  • Excellent communication skills (written and oral)
  • Attention to detail and ability to multitask
  • Good understanding of scientific principles and design of scientific studies
  • Strong teamwork skills with internal and external partners
  • Current understanding of trends of nonclinical safety assessment in the CRO landscape preferred
  • Understanding of Regulatory policies and procedures pertaining to GLP study design and reporting

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