A globally renowned biopharmaceutical organization headquartered in Cambridge, Massachusetts is seeking to hire a Study Monitor for a 6-month contract. This individual will be the liaison between the sponsor organization and the CRO.
The Study Monitor will be responsible for: 1) coordinating Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations (CROs). 2) Review study-related documents (protocols, amendments, etc.) for completeness, accuracy and consistency. 3) Perform and document CRO site visits to monitor study performance. 4) Coordinate protocol review and dose selection meetings. 5) Schedule milestones of study activities such as peer reviews as well as corresponding reports from internal and external laboratories. 6) Track reporting deliverables and graph real-time data. 7) Ensure finalization of study reports to support regulatory submissions.
Duration: 6-month CONTRACT
Compensation: $50-53 per hour
Travel: 75% (international & domestic)
- Education: Bachelor's degree is highly preferred
- Must have 5+ years of experience within a pharmaceutical organization(s) and/or CRO(s).
- Ability to travel up to 75% both domestically and internationally AALAS certification is highly desirable
- Good working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
- Must possess excellent communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.