CLINICAL SYSTEMS ANALYST WITH SECURITY CLEARANCE
Blu Omega LLC
Bethesda MD 20810 US
We are seeking a Clinical and Business Systems Analyst who specializes in eTMF systems to support a growing team with our Federal Health client on a Hybrid Basis in the DC area. Overview: 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. Responsibilities: 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.
Qualifications: 3+ years of experience working as a business analyst, including writing documentation and drafting workflow diagrams
1+ years of experience working in Trial Interactive 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
Ability to be on site up to 3x per week for the first three months and 1 time per week following.
What Blu Omega Can Offer You: Competitive benefits including Health Insurance, 401K, Paid Time Off and more.
Results driven culture that embrace our core values
Rewarding work contributing to our Nation’s mission critical programs
Blu Omega is a Woman Owned Small Business Federal Technology services firm headquartered in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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.
Qualifications: 3+ years of experience working as a business analyst, including writing documentation and drafting workflow diagrams
1+ years of experience working in Trial Interactive 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
Ability to be on site up to 3x per week for the first three months and 1 time per week following.
What Blu Omega Can Offer You: Competitive benefits including Health Insurance, 401K, Paid Time Off and more.
Results driven culture that embrace our core values
Rewarding work contributing to our Nation’s mission critical programs
Blu Omega is a Woman Owned Small Business Federal Technology services firm headquartered in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.