Myticas Consulting is currently seeking a Clinical BSA Experience for a contract position with our direct client based in North Chicago, IL.
Top skills requirements:
- Experience creating SDLC documents
- Great communication skills – ability to communicate with both business and developers
- Experience in both Agile and Waterfall environment for SDLC
The Business System Analyst (BSA) will be accountable for the following working under BRM Business System Consultant and Project Manager direction:
• Understand the functional User Stories in detail and update the User Requirements Specification/ Functional Requirements Specification (URS/FRS) Document at each Sprint Level.
• Work closely with Business Systems Owner to define requirement criticality (Critical/Non Critical/Other) and update the URS/FRS accordingly.
• Work very closely with the Validation Team during the validation testing phase of the project and involve other project resources as needed.
• Participate in the requirements sessions scheduled with the vendor to understand business requirements in detail.
• Update Configuration Document as needed based on the requirements.
• Analyze opened issues by Project team QA resource, Validation team and end users and identify if the issue is a defect or a new requirement.
• Update the Change record to populate the required content, identify the required deliverables by discussing with team, get the change record peer reviewed and approved.
• Document User Acceptance Letter, Identification of Supporting System Document and Risk Assessment Document.
• Perform system testing as needed
• Participate in and sometimes lead Agile Ceremonies such as daily stand up meetings, Sprint Planning sessions and Sprint Demonstrations to understand the implementation of the functionality.
Key Skills – Required:
• Minimum 5 to 7 years BSA experience required.
• BS degree Computer Sciences or related field
• Experienced in writing requirements for projects in pharmaceutical company is a MUST.
• Experience in developing risk assessments, validation plans, protocols, test scripts and reports that support the qualification and validation of GxP systems.
• Collaborative, positive, self-motivated, team player.
• Experienced in working with multiple groups and cross functional departments.
• Experienced in managing technology deliverables or documents from requirements through implementation.
• Strong communication skills; verbal and written
• Experienced with MS Outlook, Visio, PowerPoint, Word, Excel.
• Work on SLDC documents such as User Requirements (URS), and Functional Requirements (FRS) documents and User Acceptance (UAT) Letter
• Previous working experience in Agile methodology
Nice to have:
• General working knowledge of Clinical study activities
• Experience with Clinical systems highly valuable
• Working experience JIRA