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Clinical Study Manager (Morrisville, NC)
By | July 27, 2009
Beckman Coulter Genomics Inc. , Formerly Agencourt Bioscience and Cogenics, , is a leading provider of genomic services and nucleic acid purification products in the life sciences market
By combining the resources and expertise of two industry leaders, Agencourt Bioscience and Cogenics, into one company, something of extraordinary value has been created. With a wider range of services. Greater flexibility. The latest technology. And a total commitment to serving your needs.
You want and deserve only the best for your research. At Beckman Coulter Genomics, well make sure you get it.
The primary purpose of the Study Manager is the administration of FDA and/or other clinical studies representing the single point of study control. The study Manager has overall responsibility for designing and technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results. The Study Manager is also responsible for client management and providing advanced scientific expertise and problem solving abilities to maintain ired. All work is to be performed in accordance with applicable Good Laboratory Practices (GLP), CLIA and Good manufacturing Practices (cGMP) as required.
Responsibilities:
Provide expert guidance to customers by developing cost-effective and solution based strategies to
o Detect the integration (copy number) or expression of the vector construct in germ lone, persistence of the vector in both targeted and non-targeted tissues
o Detect and quantify DNA or RNA viruses in cell banks and residual cell DNA in bulk product
o Develop and validate custom assays to test the safety of biologics, conduct biodistribution studies, and validate diagnostic kits in accordance with ICH guidelines
Serve as one point of contact to customers from study design to data reporting, troubleshoot or provide expert advice to solve technically complex problems, and be responsible for customer satisfaction.
Responsible for QC, data analysis, interpretation and data reporting, and trouble shooting of all technically complex projects.
As a technical expert, implement new methodologies, participate in process development, reengineering and improvement, and coordinate with laboratory management to train laboratory staff.
Coordinate with laboratory management to ensure the implementation of SOPs, schedule projects and ensure that study project strategies are executed as per the study protocol and study schedule, and in accordance with GLP/cGMP.
Assist management in the management and conduct of customer audits, and actively participate in meetings with customers.
Coordinate with Quality Assurance group (QA) to ensure project documentation is complete and of high quality, assist QA in external and internal audit response(s), and work on CAPA and/or OOS investigations pertaining to project documentation and/or lab work performed.
Provide senior level operational and, where appropriate, technical support to business development activities; participate in the scoping and preparation of proposals and other client-related initiatives.
Act as a point of resolution for escalating client issues and/or complaints, as well as internal/local concerns and complaints. Resolve and/or address escalated matters to the Management as and when appropriate.
Qualifications:
Advanced degree (PhD) in Molecular Biology or Virology with 2-4 years or MS in Molecular Biology with 4-6 years of relevant experience
Strong experience in standard molecular biology techniques with particular emphasis on cloning, PCR, sequencing, Southern/Northern Blot Analysis, Quantitative PCR, and microbiology is required
Strong interpersonal, verbal and written skills and an aptitude to provide extreme customer focus is a MUST
Prior experience in cell line characterization, biodistribution, biosafety and bacteriophage testing in GLP/cGMP environment is a plus
Apply online at www.beckmancoulter.com for job number 61816.
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