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Research Investigator/Study Monitor

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

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Research Investigator/Study Monitor

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Job ID R0036482 Date posted 05/06/2021 Location Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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

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No Phone Calls or Recruiters Please.

*LI_RM

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0036482
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