Clinical Systems Analyst

Clinical Systems Analyst

The 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 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.

Join us. The world can't wait.

You Have:

• 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

  

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 Belong 

Diverse 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 Journey 

At 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.

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 ca