eTMF Business Analyst

eTMF Business 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 a business analyst, you’ll develop your skills in both. You’ll serve as a business analyst and technical SME of an enterprise electronic Trial Master File (eTMF) system directly working with the project team supporting the installation, configuration, onboarding of users, and maintenance of the system to support clinical research.

As a business analyst on our team, 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 internal and external user training and train-the-trainer training sessions, establishing and maintaining user reference materials for all user types and supporting user access and eTMF permissions. You'll demonstrate knowledge and understanding of GxP, ICH guidelines, and regulatory requirements for clinical research and TMFs. You'll also establish and maintain processes, work instructions, and other documentation to support the management of enterprise eTMF software. This position is open to remote delivery anywhere within the U.S., to include the District of Columbia.

Join us. The world can’t wait.

You Have:

• 3 years of experience working as a business analyst, including writing documentation and drafting workflow diagrams

• 1 years of experience working in Veeva Vault eTMF system, including system configuration 

• Experience delivering verbal and written presentations and communications

• Knowledge of GCP and TMF governing regulations, including the TMF Reference Model, and 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 a security clearance

• Bachelor's degree

Nice If You Have:

• Knowledge of clinical trials and research programs is a plus 

Clearance:

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information.

Compensation:

At Booz Allen, we celebrate your contributions, provide you with opportunities and choice, and support your total well-being. Our comprehensive benefit offerings include healthcare, retirement plan, insurance programs, commuter program, employee assistance program, paid and unpaid leave programs, education assistance, and childcare benefits.

Final salary will be determined based on various factors. The proposed salary range for this position in Colorado is 75,000 to 90,000.

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:

• experts in virtually every field

• a culture that focuses on supporting our employees

• opportunities that provide stability while offering variety

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.

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.