Clinical Systems IT Project Manager

Company: Booz Allen Hamilton
Location: Rockville
Posted on: June 12, 2022

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.

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Keywords: Booz Allen Hamilton, Rockville , Clinical Systems IT Project Manager, IT / Software / Systems , Rockville, Maryland