Study Monitor
Location:
Posted:
September 22, 2016
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%



we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

Schedule
Full-time
A little about us:
Takeda fosters an inclusive environment where all employees are empowered, supported and inspired to use their unique talents toward our mission to serve patients.

Know someone who would be interested in this job? Share it with your network.