13 days old

IT Compliance Business Analyst (Senior Consultant, Biotech/Pharma)

Project Outlier
San Diego (Remote), California Work Remotely
  • Payrate
    $100,000 To $120,000 Yearly
  • Job Type
  • Job Status
    Full Time

If you want to join an exceptional team of talented professionals fueling clients to deliver life-changing therapies, you’ve come to the right place!


We are seeking a service-oriented problem-solver who works well with others, communicates exceptionally well, and demonstrates a history of successfully leading and advising life sciences organizations through global technology transformation, business process improvement, and acquisition and divestiture digital technology transformations to position clients for future growth.


What you'll accomplish as a Senior IT Compliance Business Analysis Consultant at Project Outlier:

  • Lead efforts to capture business, technical, and data migration requirements.
  • Serve as systems analyst/technical resource and subject matter expert (SME) for the Biostatistics business unit or clinical data platforms
  • Lead testing to ensure implemented solutions meet requirements.
  • Deliver functional, non-functional requirements, use cases, user stories, and user interface designs.
  • Create design and xQuery documents, and data migration protocols
  • Prepare business process documentation including end-to-end data flows, testing plans, test scripts, training, and communication materials. Generate current and future state process flow, data flow diagrams, and standard operating procedures.
  • Be a quick learner and be able to understand new systems and applications, to help drive IT and business solutions forward.
  • Utilize project management processes and tools to facilitate the delivery of client deliverables.
  • Lead stakeholder and project/client team meetings to drive project and client needs, critical changes, and milestones forward.
  • Prioritize effectively by meeting deadlines and offering fast turnaround times when requested.
  • Work in complex and fast paced environments, while being able to drive progress to meet tight deadlines.
  • Keep stakeholders sufficiently informed on your progress with initiatives or deliverables.
  • Strive to proactively identify problems, determine options to address problems, identify pros and cons of potential options, and recommend potential solutions.
  • Work with other client team members and vendor personnel to implement solutions.


To thrive here, you will continuously exhibit our core values:

  • Personal Responsibility. We are as strong as our weakest link so we individually strive to be the best we can be. We lead ourselves well, are self- disciplined, take responsibility for our own growth and development, are organized, maintain the highest ethical standards, and bring a positive outlook to work every day. We work hard even when nobody is watching.
  • Expertise. We hold a wealth of knowledge, and know how to define, lead, and execute projects that achieve positive results. We also know what we don’t know, and thus continually expand our current knowledge, deepen and develop new skills, obtain marketable credentials, and build valuable experiences.
  • Productivity. Actions speak louder than words. Results speak louder still! We focus on substantial improvement and deliver it with the right quality and in a timely fashion. We solve problems, create positive change, and deliver lasting improvements for ourselves and our clients. Simply put, we get stuff done!
  • Teamwork. One for all and all for one; we succeed or fail as a team. We listen attentively, speak candidly, and treat others respectfully. We communicate effectively, collaborate, foster trust and cohesion, and promote healthy competition that pushes ourselves to be our individual and collective best.
  • Client Success. We work relentlessly to help our clients achieve their objectives. We emphasize high quality service delivery, maintain a “how can I help?” posture, execute their projects as if they were our own, and celebrate their achievements.


Your #LifeatPrO will offer:

  • A remote-first culture
  • Health/Dental/Vision with company contribution
  • PTO and Paid holidays, with added bonus of (2) one-week annual company shutdowns to provide employees ample break time
  • Tuition reimbursement
  • Company 401K contributions, even if you don’t!
  • Long-term disability/Worker’s compensation


What you'll bring:

  • Possess a relevant degree from an accredited, four-year college or university
  • Have at least 2 years of experience as a consultant or in a consultant-like role
  • Have at least five years of IT business analysis experience, with background in data integration, reporting, system implementations, and system upgrades.
  • Have strong technical background with understanding of SaaS application /COTS products, hands on experience on technologies and languages e.g. SQL, Java, AWS, SharePoint or other Cloud based platforms, experience with ETL tools etc.
  • Must possess knowledge of Sox, 21 CFR Part 11, Annex 11, GDPR, SOC 2 as it relates to computer systems validation
  • Have successfully implemented and maintained GxP regulated Biostatics and clinical data systems
  • Be able to work independently with minimal oversight, while being proactive to drive solutions to risks and issues
  • Be able to manage competing priorities across multiple projects
  • Be able to switch between priorities and change work direction and course of action as needed
  • Be willing to travel as needed (potentially one week every quarter)
  • Be eligible to work in the United States


Posted: 2023-01-13 Expires: 2023-02-27

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IT Compliance Business Analyst (Senior Consultant, Biotech/Pharma)

Project Outlier
San Diego (Remote), California

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