This position will report into the VP, Translational Research

The (Senior) Co-ordinator, Nonclinical Operations will act as study monitor and co-ordinate activities across project boundaries with other functional areas within Translational Research. The (Senior) Co-ordinator will oversee work placed at Contract Research Organisations (CROs), anticipate obstacles related to timelines and resource allocation, and will troubleshoot and resolve these obstacles. The expectation is that this individual will also serve as Study Monitor for assigned studies and represent translational research on project teams. The successful candidate will have the ability to complete work in a resourceful, self-sufficient manner and is able to design alternative approaches to achieve desired outcomes.

Key Responsibilities:

  • Responsible for operational oversight, and on-site monitoring of nonclinical studies conducted at CROs
  • Serves as Study Monitor on non-GLP and GLP-compliant studies conducted at CROs, working closely with more senior programme representatives/project toxicologists
  • Participates in the selection of CROs via technical assessments
  • Communicates timing, budget and monitor the study conduct, as appropriate
  • Collaborates with project team to develop study designs
  • Provide oversight from protocol development through reporting, including reviewing/editing reports and status updates from CROs, problem solving issues and                        providing recommendations for appropriate course of action
  • Applies thorough knowledge of GLP/regulatory requirements to all aspects of study preparation and oversight
  • May assist in the preparation of internal documents and Regulatory submissions, including authoring (under supervision)
  • Performs other duties as assigned

Required attributes:

  • Proven ability to simultaneously manage multiple highly complex short and long-term projects
  • Knowledgeable of study design considerations for all types of non-clinical studies
  • Extensive knowledge of nonclinical safety and pharmacology operations, including past study monitoring experience
  • Knowledge of national and international regulatory requirements relating to nonclinical safety studies
  • Possesses a distinguished record enabling the goals of the assigned projects
  • Demonstrates excellence in his/her own discipline and/or area of pursuit. Demonstrated strong aptitude to lead a group or team endeavour and building team unity. Demonstrated
    ability to compile and analyse study data with limited oversight
  • Excellent verbal presentation and written skills
  • Demonstrated ability to solve complex problems to attain crucial project goals

Qualifications:

  • Ph.D. (or equivalent degree) and 4-7 years relevant work experience, or
  • M.S. (or equivalent degree) and 7+ years relevant work experience, or
  • B.S. (or equivalent degree) and 10+ years of relevant work experience
  • Project Management qualification an advantage but not essential

If interested in applying for the above position please submit your CV and a covering letting to recruitment@gyroscopetx.com