Study Monitor
Location:
San Diego , California
Posted:
January 13, 2017
Reference:
1602171

OBJECTIVES:
  • Coordinates non-regulated (non-GLP) and regulated (GLP) nonclinical development studies at Contract Research Organizations (CROs)
  • Coordinates activities such as document review process including review and approval of¬† study protocols and sub reports and electronic archiving, ¬†collaborating with multiple departments (Pharmaceutical Sciences, DMPK, and QA, etc.) across Global Takeda
ACCOUNTABILITIES:

  • Provides support to DSRE Project Team Representatives
  • Coordinates protocol review and schedules dose selection meetings
  • Schedules, tracks, and monitors study progress
  • Schedules milestones of study activities such as peer reviews as well as corresponding reports from internal and external laboratories
  • Tracks reporting deliverables and graphs real-time data
  • Maintains study correspondence for assigned studies
  • Ensures finalization of study reports to support regulatory submissions
  • Performs and documents CRO site visits to monitor study performance
  • Reviews study-related documents (e.g., protocols and amendments) for completeness, accuracy and consistency
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Minimum of BS, in a scientific discipline and/or 5+ years of industry experience, previous experience working at a pharmaceutical company and/or CRO desirable. OR MS with 3+ years of experience
  • Candidate should be a self-starter, and able to work with minimal supervision to achieve objectives in a timely manner
  • Good working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
  • Experience with the design and conduct of regulated nonclinical studies and investigational studies in rodents and non-rodents
  • Strong interpersonal and organizational skills
  • Experience in reviewing study data and reports
  • Excellent communication skills and is able to effectively communicate both internally and externally in performing role as liaison between Takeda and CROs
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
LICENSES/CERTIFICATIONS:

  • AALAS certification desirable


PHYSICAL DEMANDS:

  • Routine demands of an office based environment.


TRAVEL REQUIREMENTS:

  • Ability to travel domestically and internationally, 25%



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Schedule
Full-time

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