Clinical Project Manager I

by TMG
Nov , 2
Clinical Project Manager I

The Mitchell Group, Inc., a Washington, DC based government contractor specializing in international development and clinical research work, is currently seeking a Clinical Project Manager I in Washington, DC. This position may require travel to project sites located overseas.

Key Roles/Responsibilities:

  • Responsible for providing collaborative leadership and management oversight and coordination of research projects including emerging and re-emerging Viral Disease outbreaks and response development
  • Provides oversight and coordination for a number of subcontracts (supporting research in health clinics and centers in African countries)
  • Ensures appropriate communication plans are in place to facilitate and maintain good communication channels among the many entities participating in the project (partnership leaders, US Government client teams, host country investigators/colleagues, TMG staff, subcontractors, etc.) including participating in regularly scheduled meetings/trainings
  • Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
  • Travels to project locations, as needed
  • Participates in the execution of projects and provides technical guidance in the development of administrative and operational processes, templates, procedure manuals, and other documents
  • Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet logistical and operational needs
  • Monitors progress against plans and key deliverables
  • Manages project risk by proactively anticipating issues and develops contingency plans and solutions
  • Participates in site-assessment activities to examine research competencies and capabilities, provides input for training and capacity building to enhance performance, and oversees subcontractor renovations at clinical sites ensuring that projects are accomplished, and supplies and equipment are procured in a timely manner
  • Provides assistance to clinical research teams in the development of protocol specific plans that adhere to the International Conference on Harmonization/Good Clinical Practices (ICH/GCPs), the National Institutes of Health (NIH) Standards of Clinical Research, U.S. and international regulations
  • Interacts with auditing and monitoring agencies to facilitate the exchange of information
  • Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as a liaison between government customers and subcontractors
  • Responsible for various subcontract planning, development and implementation activities, including preparing statements of work and evaluating proposals
  • Oversees and monitors the technical work of subcontractors, and performs review and verification of subcontractor deliverables and invoices
  • Performs a high degree of knowledge transfer related to project/program management concepts and practices and provides guidance and coaching to team members
  • Conducts team meetings and assists in the development of meeting agendas and summary reports
  • Prepares and reviews internal progress reports
  • Facilitates integration of new technologies with existing platforms and applications and solves hardware/software interface problems

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Educational Requirements:

  • Possession of a master’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health. (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency

Basic Qualifications:

  • In addition to the educational requirements, a minimum of five (5) years of progressively responsible, relevant experience in clinical research
  • Must be detail-oriented, creative and flexible
  • Strong organizational skills and the ability to prioritize multiple tasks and projects
  • Exceptional written and oral communication skills
  • Ability to work in an international clinical research setting both independently and within a team
  • Previous project management and/or study coordination experience including data management, and research subcontracting
  • Extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
  • Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
  • Experience related to clinical operations (e.g., development of Standard Operating Procedures (SOPs), staff development and training, resourcing/staffing, and budget planning and execution)
  • Ability to work diplomatically with regulatory agencies within complex international environments
  • Demonstrated success in previous positions in deployment and implementation processes
  • Understands data management systems and electronic data capture methods
  • Must be able to obtain and maintain a security clearance

Additional Information:

Applicants are strongly encouraged to attach a resume, cover letter, and list of 3 references in their application.
E-mail Application to: juliew [at] the-mitchellgroup [dot] com.

Please submit your application by December 22, 2019.

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