Study Monitor, Clinical and Non-Clinical Studies
Proclinical is currently recruiting for a Study Monitor for a global Pharmaceutical company located in Cambridge, MA. Successful candidate will coordinate Regulated (GLP) and Non- GLP nonclinical development studies at Contract Research Organizations (CROs)
- Coordinate protocol review and dose selection meetings
- 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.)
- 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
Skills and Requirements:
- BS desirable, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO
- Experience with the design and conduct of regulated nonclinical studies
- Strong interpersonal and organizational skills
- Experience in reviewing study data and reports
- 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
- Excellent communication skills and is able to effectively communicate both internally and externally in performing role as liaison between Company and CRO
- Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
- AALAS certification desirable
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.