Experienced Clinical Project Manager
Technical Resources International Inc.
Areas of Expertise Desired:
Key responsibilities include interfacing with the client and project staff, including task area managers, who oversee the day-to-day operation for multiple tasks areas with constantly shifting priorities. The multi-disciplinary project teams are responsible for carrying out various clinical trial Sponsor activities such as medical writing, site regulatory document collection and site monitoring, the collection and processing of adverse events reports and coordination of safety oversight committee reviews, while ensuring project compliance with FDA Regulations and with NIH Policies.
Requirements include an advanced degree in a scientific discipline, with at least 8 to 10 years proven management experience in the pharmaceutical or biotechnology industry, working knowledge of FDA requirements, GCPs/ICH guidelines; and hands on regulatory, clinical operations, or monitoring experience. Experience in drug safety and in interacting with IT development is essential; the use and development of clinical research databases, such as EDC or CTM, and the introduction of system enhancements to support process/data quality improvement would be a plus. Strong facilitation, presentation, problem-solving and conflict resolution skills, as well as seasoned oral and written communications skills, are required.
Submit resume with salary requirements to Attn: MH, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to HR@tech-res.com.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.
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