- 4+ years of experience working in clinical systems, including LIMS, eCTD, eTMF, EDC and eQMS
- 3+ years of experience working as a business analyst, including writing documentation and drafting workflow diagrams
- Experience providing verbal and written presentations and communications
- Knowledge of GCP and governing regulations, such as the TMF Reference Model, GAMP5 for Computer Systems Validation, and 21CFR Part 11
- Ability to build and maintain positive relationships with management, peers, customers, and stakeholders
- Ability to take a high degree of initiative and work independently
- Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
- Bachelor's degree
- If this position is listed as remote or hybrid, you'll periodically work from a Booz Allen or client site facility.
- If this position is listed as onsite, you'll work with colleagues and clients in person, as needed for the specific role.
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Clinical Systems Analyst - Rockville, United States - Booz Allen Hamilton Inc.
Description
Clinical Systems AnalystThe Opportunity:
Are you looking for an opportunity to establish processes and support technology innovation? You know that true progress is made at the intersection of business and tech, and as an IT Business Analyst, you'll develop your skills in both.
You'll work with systems like enterprise electronic Laboratory Information Systems (LIMS), Trial Master File (eTMF), electronic Quality Management Systems (eQMS), electronic Clinical Trial Data (eCTD), Electronic Data Capture (EDC), and others.
Work will include directly working with the project team supporting the installation, configuration, onboarding of users, and maintenance of the systems to support clinical research.
You'll support the project team in requirements gathering, developing documentation to support GAMP5 Computer Systems Validation, and qualification testing.
You'll coordinate with the project team and vendor to ensure the instance of the software complies with research and regulatory requirements.
You'll lead user training for both internal and external and train-the-trainer training sessions, establish and maintain user reference materials for all user types, and support user access and permissions.
You'll demonstrate your knowledge and understanding of GxP, ICH guidelines, and regulatory requirements for clinical research, and establish and maintain processes, work instructions, and other documentation to support the management of enterprise clinical systems.
Join us. The world can't wait.You Have:
Vetting:
Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.
Create Your Career:
Grow With Us
Your growth matters to us-that's why we offer a variety of ways for you to develop your career.
With professional and leadership development opportunities like upskilling programs, tuition reimbursement, mentoring, and firm-sponsored networking, you can chart a unique and fulfilling career path on your own terms.
A Place Where You BelongDiverse perspectives cultivate collective ingenuity.
Booz Allen's culture of respect, equity, and opportunity means that, here, you are free to bring your whole self to work.
With an array of business resource groups and other opportunities for connection, you'll build your community in no time.Support Your Well-Being
Our comprehensive benefits package includes wellness programs with HSA contributions, paid holidays, paid parental leave, a generous 401(k) match, and more.
With these benefits, plus the option for flexible schedules and remote and hybrid locations, we'll support you as you pursue a balanced, fulfilling life-at work and at home.
Your Candidate JourneyAt Booz Allen, we know our people are what propel us forward, and we value relationships most of all.
Here, we've compiled a list of resources so you'll know what to expect as we forge a connection with you during your journey as a candidate with us.
CompensationAt Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being.
Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care.
Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values.Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs.
Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits.We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.
Salary at Booz Allen is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements.
The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen's total compensation package for employees.
This posting will close within 90 days from the Posting Date.Work Model
Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely.
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.
