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Study Director

Boston, MA

Company Description

Cambridge Biomedical is a contract laboratory service organization that works with biotechnology, pharmaceutical and reference laboratories. We specialize in custom assay development, qualification and validation.  Assays are performed in our CLIA / CAP accredited laboratory.  Testing capabilities include clinical trial, diagnostic, and biosafety testing. Cambridge Biomedical offers a wide variety of analytical technologies in microbiology, immunology, molecular biology and clinical chemistry including HPLC, ELISA, and RIA, Cell Based Assays, Cell Culture, RT PCR, Colorimetric Assays and Spectroscopy.  We are experts at solving assay development problems.

Job Description

Study Director will manage assigned projects and sponsor/Cambridge Biomedical relationships to ensure the successful completion of projects. As the single point of study control the Study Director will:

 

  • Have overall responsibility for the scientific conduct of assigned studies
  • Confirm the compliance of the study in accordance with the OECD Principles of Good Laboratory Practice, Cambridge Biomedical and/or Sponsor SOPs, guidelines and requirements.
  • Be responsible for technical conduct, documentation, analysis, interpretation, reporting and archiving.
  • Be responsible for the creation of project plans and tracking of milestones 
  • Monitor the scheduling, pricing, and technical performance of clinical programs/projects. 
  • Develop solutions to project issues
  • Act as an advisor to project teams regarding projects, tasks and operations.
  • Authorize modifications and document reasons for modifications
  • Proactively identify issues and develop strategies for assuring study timelines are met and assuring quality deliverables
  • Ensure protocols are available to study team, QA staff and any Principal Investigators.
  • Oversee the preparation and distribution of materials for project and sponsor meetings including minutes and agendas
  • Sign and date the final report accepting responsibility for the validity of the data and GLP compliance
  • Archive all raw data, documentation, protocols, specimens and final reports

Qualifications

The position requires a minimum of a Bachelors degree in the field of Biomedical Sciences, Chemistry, Molecular Biology or Biological Sciences with 3-5 years in the role of Study Director and clinical experience in the pharmaceutical industry.  A Masters and/or MBA and/or formal training in project management are highly desirable. The individual must be familiar with GLP/CAP/CLIA regulations, possess excellent written and verbal communication skills, be able to define and interpret regulatory language, and be proficient in Office applications (Word, Excel, Powerpoint, Outlook and Project Management Software).

Additional Information

Interested individuals should submit a cover letter, resume and salary requirements to hr@cambridgebiomedical.com