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:
- 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, 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
- AALAS certification desirable
- Routine demands of an office based environment.
- 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
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.
San Diego, CA