Clinical Project Manager

Location: Hamilton, Montana
Date Posted: 12-18-2018
About Us:
Fidelity Partners is a leading national healthcare, technology and logistics services company supporting both private and government sector clients. We are committed to the highest levels of professionalism and work ethic to cultivate long-term relationships.  We offer competitive pay with comprehensive benefits package.  For more information about Fidelity, please visit our website at www.fidelitypartners.org

We are currently accepting qualified applications for a PROJECT MANAGER to support one of our Government Clients at Hamilton, Montana. In this position, you will have the opportunity to work with The National Institute of Health (NIH), one of the most prestigious research organizations in the world.  
 
Job Summary:
 
The contractor shall provide expertise to the National Institutes of Health (NIH) by providing professional expertise in microbiology molecular biology, biochemistry, infectious diseases, immunology, and bioinformatics; and cutting-edge vaccine research to improve understanding of immune responses and to identify new vaccine targets for HIV/AIDS, malaria, influenza, Ebola, Zika, and other pathogens and diseases. 

Position Objective:
The contractor shall provide expertise to the National Institutes of Health (NIH) by providing responsibility for overall project coordination and communications, tracking, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines.
 
Duties and Responsibilities
Typical tasks that are assigned may include:
  • Some travel may be required
  • Coordinates and completes projects
  • Oversees all aspects of projects; sets deadlines, assigns responsibilities; monitors and summarizes progress of project
  • Prepares reports for upper management regarding status of project
  • Leads and directs the work of others
  • Translates complex requirements into specifications for project completion
  • Acts as liaison with other agencies and organizations when necessary for project completion
  • Researches new trends in project management and related technology.
  • Assists with developing project budgets and ensuring that costs are contained.
  • Develop regulatory strategies appropriate for manufacturing clinical products for Phase I, II, and III trials, e.g., planning, reviewing, and overseeing manufacturing methods, toxicology protocols, and preclinical packages.
  • Make recommendations regarding alternative serotypes for adenoviral vector vaccine candidates, and assessments of direct viral load and viral immunology studies in concert with VRC researchers.
  • Possess project management skills and ability to synthesize project workloads.
  • Responsible for chemistry, manufacturing, and controls (CMC) of all investigational new drug (IND) applications for vaccines and related products and oversee the planning, preparation, and review of IND materials to ensure compliance with FDA guidelines and the Code of Federal Regulations (CFR).
  • Provide expertise for testing and characterizing strategies for cell substrates, vaccine constructs, and vaccine formulation.
  • Responsible for assembling all CMC IND packages for integration and submission to regulatory authorities by other intramural or extramural agencies.
  • Work with VRC and NIAID staff and participate in an overall team approach involving high-visibility projects within VRC, NIAID, NIH, and the scientific community.
  • Serve under the general supervision of the director of the VPP, who provides broad administrative and scientific direction.
  • Advice, information, and recommendations developed by the incumbent form the basis for decisions by the director.
  • Prepare oral and written presentations of studies for both internal and external use.
  • Contribute to manuscripts of original results that derive from IC activities, and contribute data and expertise to manuscripts from other VRC investigators in which IC data are used.
  • Develop visual and written communication products associated with the NIH, NIAID and VRC brand.
  • Provide broad design, production, and photography services, including development of publications and of marketing materials and signage for VRC events; advertising and outside content review; logo use and policy; branding development and related special initiatives; poster and program development; medical illustrations; other graphic design projects.
  • Provide turnkey video and animation services, including client consultation; concept/script development; planning and location scouting; filming, storyboarding, editing and other post-production services; closed captioning; maintenance and updating stock of B-roll footage; development of video-related infrastructure, such as digital asset management and storage solutions, and overall project management for video projects.
  • Assist with the development and management of content for digital signage, including template development; content targeting and refreshment; maintenance of digital signage; media inquiries and interview requests, content for press releases, byline articles and keynote presentations, and public relations needs that increase the effectiveness of visual communications products in meeting the needs and requirements of the VRC.
  • Conduct and direct ongoing evaluations to measure the success of communications plans and programs that support and promote overall goals, research, and programs, ensuring that all messages, materials, and strategies for target audiences are credible, clear, and meaningful.
  • Collaborate with divisions and other offices to increase the effectiveness of communications strategies and services in meeting the needs and requirements of the Institute.
  • Ensure that VRC communication functions are effectively coordinated with IT staff, including obtaining technical policy, advice, and assistance from the OCICB, and interacting with OCICB to assess the VRC's IT applications and systems and determine appropriate technology solutions to support the communication and dissemination of VRC information via various external and internal communications vehicles.
  • Perform quality control assessments on all outbound written responses. Ensure documents are prepared in accordance with office policies and procedures, including reviewing, revising, and editing as needed. Ensure responses conform to applicable regulations, style manuals, and publication standards. Review and analyze documents for logical, well organized structure. Check and verify information for accuracy and consistency using a broad variety of Internet sources such as PubMed, Medline, and other Web sites and search engines. Act as an information resource to other health communications specialists in developing comprehensive and appropriate responses to mail, telephone, fax, and email inquiries from the public.
Minimum Qualifications:
  • Bachelor’s Degree in a related field (4 years specialized experience + High School Diploma in lieu of BA/BS)
  • Minimum of two (3) years of experience in a related field
  • Proficiency with Microsoft Office Suite (MS Word, Excel, Outlook)
Thank you for providing us your candidacy request we will review your background and qualifications to determine a potential match for this opportunity, if we determine you are a good fit one of our executive recruiters will contact you as soon as possible to discuss next steps, if you are not we will retain your information in our database for future opportunity.

Kindest Regards,
Fidelity Partners
https://www.fidelitypartners.org
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