Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently seeking a Clinical Project Manager to join our Bethesda, MD team. They will oversee the activities of at least two Task Areas in support of a large contract with the National Institutes of Health (NIH).
Key responsibilities include interfacing with the client and project staff, including other task area managers who oversee the day-to-day operation for multiple tasks areas with constantly shifting priorities and strict processing timelines. The multidisciplinary 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 quality and 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 the review and tracking of essential regulatory documents for clinical site participation in trials, including review of site informed consents against templates to ensure inclusion of critical elements/language, e.g., future use, NIH policy and Human Subject Protection language, and prior project or line oversight of site monitoring activities is critical. A background in Infectious Disease/HIV clinical trials would be a plus.
Strong facilitation, presentation, problem-solving and conflict resolution skills -- including the ability to keep up with rapid changes of priorities, seasoned oral and written communications skills, strong attention to detail and ability to QC information. Demonstrated ability/experience interacting with IT, 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 are critical to ensure success in this position.
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 firstname.lastname@example.org.
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.