Scientific/Clinical Project Leader
- Boston, MA
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.
Cambridge Biomedical is seeking a Project Leader to manage assigned projects and proactively manage sponsor/Cambridge Biomedical relationships to ensure the successful completion of projects. The Project Leader will:
- Have overall responsibility for the scientific conduct of assigned projects
- Confirm the compliance of the project in accordance with the OECD Principles of Good Laboratory Practice, Cambridge Biomedical and/or Sponsor SOPs, guidelines and requirements.
- Be responsible for documentation, analysis, interpretation, reporting and archiving of projects.
- Assist in the development of project plans and tracking of milestones
- Monitor the scheduling and technical performance of clinical programs/projects.
- Develop solutions to project issues
- Act as an advisor to project teams regarding tasks and operations.
- Authorize modifications and document reasons for modifications
- Proactively identify issues and develop strategies for assuring project timelines are met and assuring quality deliverables
- Ensure protocols are available to project 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
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 as a Project Leader with clinical experience in the pharmaceutical industry or equivalent. A Masters and/or MBA and/or formal training in project management are highly desirable. The individual must possess excellent written and verbal communication skills, be able to define and interpret regulatory language, be familiar with GLP/CAP/CLIA regulations, and proficient in Microsoft Office applications.
Interested individuals should submit a cover letter, resume and salary requirements to firstname.lastname@example.org