Overview

A major research-based biopharmaceutical company was working with a commercial LIMS vendor to implement a LIMS for the Biometrics department. Both the biopharmaceutical company and the LIMS vendor had project teams which interfaced closely to move the project forward.

As the project proceeded, it became clear that the biopharmaceutical company was lacking a business analyst that could work with their internal informatics project team to collect and document user requirements, and then interface with the LIMS vendor team to translate those user requirements into functional system requirements. In order to effectively fulfill this role, the candidate needed:

• Strong business analyst skills
• Familiarity with the lab environment
• Subject-matter expertise – specifically, the candidate needed to be very knowledgeable around the topic of biomarkers
• On-site at least 75% of the time
• Familiarity with the commercial LIMS that was being implemented
• Familiarity with Agile/Scrum project methodology
• Ability to comfortably interface with all levels within the client and vendor organizations, from developers and bench scientists through to the Steering Commit­tee and senior management stakeholders

Services Provided:

To assure that the best candidates were selected for review, the recruitment process began with a Prescreening stage that assessed the fit for the position and company in question. In this case, the standard vetting process handled by the Staffing team was augmented with a second level screen done by members of the Professional Services team in order to evaluate the candidate’s technical knowledge of the commercial software platform.

The Astrix Recruitment Process

Results Delivered:

Application of the staffing recruiting engine, combined with the technical and sub­ject-matter expertise of our Professional Services team, delivered the best candidate to meet the needs of the bio­pharmaceutical company. The result? A high-quality, difficult to source candidate was delivered on-site that fulfilled all the necessary requirements in just 28 days.

The business analyst performed the following functions to support the success­ful implementation of the commercial LIMS solution:

• Met with Biometrics department leaders to get a high-level overview of the current environment and their vision for the future.
• Interviewed members of several groups within the Biometrics department to under­stand their functions, workflows, business processes, and how the departments work cross-functionally within the company.
• Performed workflow analyses and identified pain points, gaps, and requirements for each group within the department.
• Analyzed and mapped the company’s over­all clinical research process and presented to the company business team how the commer­cial software system fit cross-functionally in the workflows.
• Reviewed previous work and documenta­tion, led iterative meetings with the business process owners and Project Manager to author the company’s User Requirements Specifica­tion (URS) for the commercial LIMS solution designed to support Biomarker Assay Manage­ment.
• Worked with the LIMS vendor and the biopharmaceutical company on the Proof of Concept (POC) and Implementation phases of the system through several sprints, which included testing, tracking, and resolving issues via the quality management software.
• Supported script generation for validation purposes by leading a number of iterative meetings with the biopharmaceutical