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Research
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80893 Requisition #
Thanks for your interest in the Clinical Trials Regulatory Manager position. Unfortunately this position has been closed but you can search our 859 open jobs by clicking here.
DESIRED QUALIFICATIONS:
  • Experience developing, writing and maintaining standard operating procedures (SOPs) and other quality documents
  • Experience teaching regulatory principles, concepts and operational information
  • Experience with quality monitoring and/or auditing clinical research studies
  • Experience with process excellence processes and evaluation
EDUCATION & EXPERIENCE (REQUIRED):
  • Bachelor’s degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience. 
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
  • Experience in clinical research management and oversight, including project management in a dynamic research setting. 
  • Experience in a lead role and interactions with federal agencies, i.e. FDA. 
  • Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice. 
  • Knowledge of International Conference on Harmonization (ICH) standards.
  • Experience in developing and implementing multifaceted projects. 
  • Excellent communication and organizational skills and superb attention to detail. 
  • Experience with MS Office products and database applications required. 
  • Strong written and verbal skills.
PHYSICAL REQUIREMENTS*:
  • Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
  • Occasionally sit, use a telephone or write by hand. 
  • Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommoda
tion to perform the essential functions of his or her job.
 
WORKING CONDITIONS:
  • May require occasional local and overnight travel.
WORK STANDARDS:
  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.


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