- Requirements gathering:
- Collect, analyze, organize, and write system requirements for both initial and subsequent builds. Ensure proper and clear understanding of requirements by client and internal team members.
- Lead requirements review meetings. Elicit requirements through use of interviews, document analysis review (protocol / supporting documents), requirement meetings with client teams (teleconference and in person as needed), business analysis, and client need.
- Identify key stakeholders and define their responsibilities related to requirements definition, assessment, and approval. Communicate with the client and other stakeholders to understand their project objectives.
- Critically evaluate requirements gathered from multiple sources, reconcile conflicts, act as consultant by providing best practices and lessoned learned, and separate user ‘wants’ from the true needs.
- Write clear, concise, and detailed system requirements to meet the client’s needs while supporting Almac goals.
- Collect, analyze, organize, and write system requirements for both initial and subsequent builds. Ensure proper and clear understanding of requirements by client and internal team members.
- Systems Build:
- Ensure the internal team has a full understanding of the project requirements. Ensures the internal team delivers a quality system that meets the requirements documentation. This will be done by the Design Manager by leading requirements review meetings, attending functional and test case reviews, and participating in regular status meetings.
- Systems Implementation:
- Perform and support client user acceptance testing. Participate in any other required implementation activities on a project specific basis.
- Project Scope Assessment:
- Understand initial project scope and initiate conversations about scope during requirements gathering with Project Manager and client. Provides estimates for level of effort for requested changes to scope during initial and subsequent builds.
- Risk Management:
- Actively participates in identifying, mitigating and managing risk and raises concerns to client and internal team as appropriate.
- Associate’s degree with a minimum of two (2) years of industry related experience OR Bachelor's degree
- 1+ years of experience communicating directly with clients
- 1+ years of experience managing multiple projects or tasks simultaneously
- 1 year of experience understanding client requirements
- Proficient knowledge of Microsoft Office products, especially Word, Excel and PowerPoint
- Bachelor’s Degree
- 1+ year working experience with clinical trials, or in pharmaceutical or biotechnology environment
- 1-3 years of experience gathering and writing technical requirements
- Experience understanding and writing client requirements
- Experience gathering IXRS requirements
- 3 years of experience communicating directly with clients
- Experience managing multiple projects or tasks simultaneously
- Use of Requirements Management Tools and Processes, e.g. Microsoft Team Foundation Server (TFS), SharePoint, Wireframing Tools, etc.
- Experience within the clinical technology, life sciences or software industries setting
- Understanding of use of IXRS in Clinical Trials
- Knowledge of the clinical trial process
- Knowledge of system development life cycle (SDLC)
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Hybrid work available for applicable roles
- Professional development programs/ continuous learning opportunities