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Research Investigator/Study Monitor

応募後で応募 求人ID R0036482 掲載日 06/15/2021 Location:Boston, Massachusetts

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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 Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Study Monitor working on the Global Preclinical and Translational Sciences team, you will be empowered to coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations and perform and document CRO site visits to monitor study performance, and a typical day will include:

POSITION OBJECTIVES:

  • 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 

POSITION 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, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • Minimum of BS, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO
  • 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

This job posting exclude Colorado applicants

LICENSES/CERTIFICATIONS:

  • AALAS certification desirable

TRAVEL REQUIREMENTS:

  • Ability to travel domestically and internationally, 50%

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs 

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

*LI_RM

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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