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Clinical Trials Project Leader I

OCCUPATIONAL SUMMARY: The Project Leader I position provides leadership to the department and to projects for application of information technology and health services research data management.  This includes identifying research and business objectives and informatics solutions utilized in clinical research and health services data management operations. This can include translational, clinical research, health service policy projects.  The Project Leader has knowledge of biomedical informatics practices including medical computing, terminology, healthcare and research data systems and health information exchange, including the use of electronic health data, including claims data, in clinical and policy research.  Oversees assigned projects and is active in developing more efficient and effective data management support for research projects supported by the department.  Close collaboration with other functional areas within department and across the facility, and external organizations is necessary. 
The Project Leader I typically leads the operations on one or more biomedical or policy research projects of average to moderate complexity, at times with oversight of a more senior Project Manager.
Administrative Management:

  • Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others
  • Manages staff, supports and contributes to the administrative processes for the group and overall department.
  • Holds responsibility for and provides technical, fiscal, and management oversight for assigned projects and tasks. Projects may be of moderate complexity or pieces of larger projects managed by a higher level Project Manager. 
  • Provides service-oriented support to other functional sub-groups, departments and project teams.

Project Leadership:

  • Provides leadership on behalf of the project and organization to ensure success of research endeavors.
  • Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.
  • Responsible for assuring that timelines, costs and deliverables of projects are well managed.  This will often require external relationships and managing subcontracts.
  • Contribute to business development activities for projects such as presentations to prospective sponsors, development of scope of work, contract assumptions and cost estimates.
  • Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements
  • Capture experiences and lessons learned as routine part of project lifecycle.
  • Create routine mechanisms for informatics and PHSR issues to be collected and communicated on project teams.
  • Manage internal and external customer expectations.
  • Identify and ensure compliance with regulations and policies.

REQUIRED QUALIFICATIONS Education/Training: Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus 2 years of healthcare experience; or one of the following equivalents:

  1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiological Technology, Licensed Practical Nurse) plus a minimum of 5 years healthcare experience; or
  2. Completion of a Master’s degree in Public Health, Health Administration or a related area with 1 year directly related clinical trials research experience; or
  3. Completion of a Bachelor’s degree plus a minimum of 3 years directly related experience in clinical trials research; or
  4. Completion of a bachelor’s degree plus a minimum of 4 years closely


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