Research Investigator/Study Monitor
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!
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
- Results Driven
- Team Player
Life at Takeda
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Research & Development
By focusing R&D efforts on four therapeutic areas and other targeted investments, our aim is to thrive at the cutting edge of innovation that solves unmet medical needs, through internal R&D and in collaboration with cross-industry partners. We have the scale and expertise to be a leading global, Values-based, R&D-driven biopharmaceutical company with dynamic, focused R&D efforts.
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.
Research Investigator/Study MonitorApply Now
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:
- 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
- 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
- AALAS certification desirable
- 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.
Time TypeFull time
Job ID R0036482