Business Process Reengineering Specialist III (52611)

Gap Solutions•Bethesda, MD

About The Position

The purpose of this task is to provide quality management services in support of core task Enterprise Product Management. This will include the validation of NIAID Enterprise Clinical Informatics Systems in compliance with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) requirements, e.g. 21 Code of Federal Regulations (CFR) Part 11. The Contractor will comply with the CIB/ECIS Quality Management System (QMS) that is based on GAMP 5.

Requirements

Bachelor’s Degree is required
Requires six years of relevant experience

Nice To Haves

Ability to communicate effectively, orally and in writing, with non-technical and technical staff
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
Prior experience with Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) requirements, e.g. 21 Code of Federal Regulations (CFR) Part 11 is preferred
Prior experience working with Quality Management Systems is preferred.

Responsibilities

Responsible for a variety of Computer Systems Validation/Assurance activities and tasks.
Updating CIB systems to support health authority requirements.
Developing processes and procedures to support regulatory compliance requirements.
Supporting initial and periodic Validation/Assurance of NIAID CIB Enterprise Clinical Informatics Systems.
Responding to validation findings and taking corrective actions.
Supporting health authority inspections.
Conducting activities to maintain the validated state of NIAID CIB Enterprise Clinical Informatics Systems.
Maintain the Computer Systems Validation/Assurance of the servers and the software to ensure that the systems are compliant.
Comply with requisite FDA and other applicable international requirements for clinical research protocols.
Manage and document the access privileges for all users that access the NIAID Enterprise Clinical Informatics Systems in compliance with documented standard operating procedures (SOP), which shall be provided to the Contractor upon award.
Manage use of process improvement, reengineering methodologies, and internet-related methodologies and principles to conduct process modernization projects.
Responsible for transitioning of existing organizations or project teams in accomplishing the organization’s goals or project activities and objectives through improved use of internet and other automated processes.
Support activity and data modeling, development of modern business methods, identification of best practices, and creating and assessing performance measurements.
Provide group facilitation, interviewing, training, and additional forms of knowledge transfer.
Serve as key coordinator between customers and multiple project teams to ensure enterprise-wide integration of reengineering efforts and application of best practice including e-business practices.
May provide daily supervision and direction to other contractor business reengineering specialists and web architects.