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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Business Analyst - IT Clinical Trials

Job ID R0000002221 United States of America - Remote - Southeast

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Do you want to make an impact in your next role? Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do.

The Business Analyst will work closely with other business analysts, the business and technical teams, to elicit, refine and document requirements (ex. functional requirements, user stories and specifications) in a manner that both reflects the true need of the business, and holistically and comprehensively outlines the solution need for: IT leads, architects, and developers. Within this role the candidate needs to possess knowledge of Good Practice (GxP) quality software validation processes and operational business processes.

With a continuous improvement mindset, the Business Analyst will look for opportunities to refine processes, tools, techniques, and standards, creating efficiency within the Business Analysis process while delivering concise, complete and comprehensible requirements for features, functions, and behaviors of the needed solution(s).

Key Accountabilities:

  • Contribute to the refinement the processes & templates for Business Analysis, to make the work more efficient over time
  • Coordinate project meetings, communicate with the team, internal/external partners, and senior management
  • With support, work with the Project Manager to identify the changes, gaps, risks, issues in requirements
  • Establish and mature an understanding of project management processes and methodologies to ensure projects are delivered on time, within budget, in adherence to quality standards and meeting customer expectations
  • Develop and refine the ability to work with IT teams and explain the business and functional requirements in detail to translate the technical terms
  • Utilizing a consulting mindset and behaviors, identify the true needs of the business, and help sell the needs back to stakeholders to seek agreement
  • (Co-)Chair workshops, business interviews and requirements gathering sessions for multidisciplinary teams of SMEs, to identify needs and pursue collaborative agreement with stakeholders
  • Act as the translator, to make sure engineers understand the business, and the business understand the engineers
  • Engage Human Factor Engineering (HFE) to define requirements with a focus to make the user interface as easy for the user to understand and follow as possible
  • Act as voice of the customer in SCRUM teams, when there is no Business SME in the team
  • (Co-)Own the traceability matrix/ matrices, ensuring all requirements are tested
  • Assist in identifying technical functionality that aligns with desired new business capabilities
  • Work with business teams to provide input to the User Acceptance Test (UAT) criteria and help business in defining User Acceptance test scenarios
  • Participate in the UAT dry run and UAT execution to help cross verify the requirements

Skills:

  • Ability to generate detailed documentation of requirements based on verbal communication
  • Able to continually add to knowledgebase, and share acquired knowledge with colleagues in an efficient manner
  • Excellent communication  skills, both written and verbal
  • Native or proficiency in English
  • Skilled in MS Office tools including MS Visio, MS Excel, MS PowerPoint
  • Working experience of Onsite – Offshore model, and with highly cross functional teams preferred
  • Ability to work in a fast-paced environment
  • Ability to work on more than one issue or project simultaneously
  • Conflict resolution as it relates to people and project priorities
  • Able to take the initiative and carry out tasks independently
  • Gather and analyze business and/ or functional requirements from cross-functional client groups to help design, develop, and/or configure applications

Knowledge and Experience:

  • Experience in conducting or participating in business requirements sessions, writing business requirements, and developing use cases or user stories preferred
  • Experience in GxP SDLC Validation including 21 CFR Part 11 within an FDA regulated / Pharmaceutical, or Biotech environment preferred 
  • Experience working with or within the Pharma Industry (Pharmaceutical Company, Biotech, or CRO)  preferred
  • Experience working with any Agile product development tool (ex. JIRA) preferred
  • Demonstrated competency of/ in:
  • Clinical trials / studies, and the variation in need from Phase I through Phase IV
  • Consulting toolsets & behaviors
  • Business Analysis best practices
  • Computer System Validation best practices (SDLC)
  • Project Lifecycle best practices (PLC)

Education:

  • Degree in a life science, computer science, or other relevant experience required
  • MSc / MBA / Advanced degree preferred

Parexel Benefits:

  • Health, Vision & Dental Insurance
  • Tuition Reimbursement
  • Vacation/Holiday/Sick Time
  • Flexible Spending & Health Savings Accounts
  • Work/Life Balance
  • 401(k) with Company match
  • Pet Insurance

Full list of benefits available here: US Benefits | Parexel International

At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you’re exposed to a world of experiences and open doors.


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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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