Clinical Systems IT Project Manager
Company: Booz Allen Hamilton
Location: Rockville
Posted on: June 12, 2022
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Job Description:
Key Role:
Manage consulting engagements and technology-based IT solution
projects for clients. Apply leading-edge principles, theories, and
concepts and contribute to the development of new principles and
concepts. Work on unusually complex problems and provide highly
innovative solutions. Operate with substantial latitude for
unreviewed action or decision and mentor or supervise employees in
both firm and technical competencies.
Basic Qualifications:
5+ years of experience as a Software Project Manager
Experience with electronic common technical document (eCTD),
electronic document management systems (EDMS), electronic trial
master files (eTMF), or electronic quality management systems
(eQMS)
Experience with Good Manufacturing Practice (GMP) and Good Clinical
Practice (GCP)
Knowledge of Computer Systems Validation (CSV) and experience
managing validated systems
Ability to obtain and maintain a Public Trust or
Suitability/Fitness determination based on client requirements
Bachelor's degree
Additional Qualifications:
Experience working within the federal government
Knowledge of FDA and other regulatory health authority requirements
for IND and CTA submissions preferred
Knowledge of eCTD specifications and guidance preferred
PMP certification
Vetting:
Applicants selected will be subject to a government investigation
and may need to meet eligibility requirements of the U.S.
government client.
We're an equal employment opportunity/affirmative action employer
that empowers our people to fearlessly drive change - no matter
their race, color, ethnicity, religion, sex (including pregnancy,
childbirth, lactation, or related medical conditions), national
origin, ancestry, age, marital status, sexual orientation, gender
identity and expression, disability, veteran status, military or
uniformed service member status, genetic information, or any other
status protected by applicable federal, state, local, or
international law.
#LI-AH1, ID16-C
Keywords: Booz Allen Hamilton, Rockville , Clinical Systems IT Project Manager, IT / Software / Systems , Rockville, Maryland
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