Posted to MedZilla on 3/19/2019


Takeda Pharmaceuticals

US-CA, Study Monitor R0006380-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Study Monitor in our San Diego office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Study Monitor working on the Strategy and Operations team, a typical day will include:

OBJECTIVE:

  • Coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations (CROs)
  • Review study-related documents (protocols, amendments) for completeness, accuracy and consistency
  • Perform and document CRO site visits to monitor study performance
  • Coordinate activities collaborating with multiple departments (Pharmaceutical Sciences, DMPK, and QA, etc.) across Global- Takeda

ACCOUNTABILITIES:

  • Coordinate protocol review and dose selection meetings
  • Schedule, track, and monitor study progress
  • Schedule milestones of study activities such as peer reviews as well as corresponding reports from internal and external laboratories
  • Track reporting deliverables and graph real-time data
  • Maintain study correspondence for assigned studies
  • Ensure finalization of study reports to support regulatory submissions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • 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
  • 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 CRO
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
  • BS in a scientific discipline (or equivalent) with 4+ years of experience, or MS in a scientific discipline with 1+ years of experience, working at a pharmaceutical company and/or CRO

LICENSES/CERTIFICATIONS:

  • AALAS certification desirable

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.

TRAVEL REQUIREMENTS:

  • Ability to travel domestically and internationally, 30%

Empowering Our People to Shine

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit

http://www.takeda.us/careers/EEO_Policy_Statement.aspx

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

Locations

San Diego, CA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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