Clinical Project Manager - Emerging Infectious Diseases Branch - Bethesda, MD

Updated: April 20, 2020
Job ID: 215680
Status: Full-Time
Regular/Temporary: Regular
Location: Silver Spring, MD, United States

Join the HJF Team!

HJF is seeking a Clinical Project Manager, to support the Emerging Infectious Diseases Branch (EIDB) within the Walter Reed Army Institute of Research located in Silver Spring and Bethesda MD. HJF provides scientific, technical and programmatic support services to EIDB. 

Under the direction of the Associate Director for Programs and Operations, the Clinical Project Manager (CPM) will work with a team of Research Physicians to develop project plans and support budget development activities, track progress of assigned programmatic research studies under the purview of WRAIR and EIDB. The CPM will organize communication with study teams located in the U.S. and internationally, and integrate administrative activities supporting clinical research projects. Travel is required. 

Responsibilities:

  1. Support EIDB’s multi-site clinical projects by coordinating operational, administrative, and diverse programmatic activities.
  2. Responsible for management of the day-to-day operations of the research projects by applying comprehensive knowledge of clinical development and project management. 
  3. Assists with site development including establishing site logistics. Including, supporting the training and development of all in-country clinical staff members.
  4. Work with the project team to develop and maintain project documentation (project scope, schedule, budgets, communication plans, & etc.) and monitor progress throughout the duration of the study.
  5. Develop and manage study budgets and track any required project agreements and contracts with EIDB.
  6. Liaise and work with project area leads to ensure development of necessary study documentation, clinical database, CRFs, and ICFs. Liaise with clinical operations team lead to ensure the development of and adherence to operations documents and procedures. Liaise with regulatory team lead to ensure compliance with regulatory jurisdiction of each site and all applicable U.S. agencies.
  7. Coordinate with team leads in each project area to prepare written study-related progress reports and oral briefings. 
  8. Assist in the development and management of research proposals. 
  9. Assess risks to project performance, and independently or in collaboration with study team, develop risk mitigation proposals for consideration by responsible leadership. Implement selected mitigation plan(s) and monitor outcomes.
  10. Manage communications within project team, organize meetings and develop appropriate agendas, managing meeting minutes and their appropriate dissemination, and follow up on action items with responsible parties. Support research physicians by assisting with meeting management and the development of plans, reports and presentations as required.
  11. Maintains a thorough working knowledge of the HJF, HJFMRI, MHRP, EIDB, WRAIR, USAMRMC, and DoD operations, policies and regulations as they pertain to the work being conducted at EIDB.
  12. Report and escalate project issues to management as needed.

Required Knowledge, Skills and Abilities: Ability to work in a fast-paced research environment, and to plan and manage multiple priorities on different timelines. Flexibility to handle a variety of tasks and shift priorities as necessary. This position requires the ability to write progress reports in a clear and concise manner; excellent organizational, communication and interpersonal skills; ability to establish goals and agendas. Strong self-management and organizational skills. Excellent knowledge of clinical trial processes; thorough knowledge of GCP, human subject research, or equivalent regulations.

Minimum Education: Bachelor’s degree in Life sciences, scientific disciplines or equivalent required. 

Minimum Experience/ Training Requirements: 6 – 8 years of relevant experience. 6+ years of managing research projects, with strong clinical trials experience.

Work Environment: Office. 

Background/Security: Must have lived in the US 3 out of the past 5 years; eligible to pass a NACI background.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.  

HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
 

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