Clinical Systems Analyst Jobs

Job Number: R0170775
Clinical Systems Analyst
The Challenge:
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 serve as a business analyst and technical SME for several clinical information systems to support Clinical Trials. 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.
You Have:

• Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
• 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
• Ability to take a high degree of initiative and work independently
• Knowledge of GCP and governing regulations, such as the TMF Reference Model, GAMP5 for Computer Systems Validation, and 21CFR Part 11
• Bachelor's degree
• Ability to build and maintain positive relationships with management, peers, customers, and stakeholders

Nice If You Have:

• Knowledge of clinical trials and research programs

Vetting:
Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.
Build Your Career:
A challenging and dynamic work environment isn’t all we have to offer. When you join Booz Allen, you’ll have access to:

• Opportunities that provide stability while offering variety
• Experts in virtually every field
• A culture that focuses on supporting our employees

You’ll also be exposed to a wealth of training resources through our Digital University, an online learning portal featuring more than 5000 functional and technical courses, certifications, and books. Build your technical skills through hands-on training on the latest tools and tech from our in-house experts. Pursuing certifications that directly impact your role? You may be able to take advantage of our tuition assistance, on-site bootcamps, certification training, academic programs, vendor relationships, and a network of professionals who can give you helpful tips. We’ll help you develop the career you want as you chart your own course for success.
Compensation
At 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 projected compensation range for this position is $81,800.00 to $186,000.00 (annualized USD). 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.
Work Model
Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely.

• If this position is listed as onsite, you’ll work with colleagues and clients in person, as needed for the specific role.
• If this position is listed as remote or hybrid, you’ll periodically work from a Booz Allen or client site facility.

EEO Commitment
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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