Study Monitor

  • location: Cambridge, MA
  • type: Contract
  • salary: $50 - $55.92 per hour
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job description

Study Monitor

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $50.00 - 55.92 per hour
work hours: 8 to 4
education: Bachelors
 
responsibilities:
  • 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- Company
  • 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
 
qualifications:
  • 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 Company and CRO
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
  • BS desirable, in a scientific discipline and/or 5+ years of industry experience, working at a pharmaceutical company and/or CRO
  • Ability to travel domestically and internationally, 75%
 
skills: MS-WORD, MS-EXCEL, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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