Background

Trialspark is a technology company that brings new medical treatments to patients faster by reimagining the clinical trial process.

Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients. We’re fundamentally changing how trials are run, rethinking the trial process both from a technology and operational perspective. To achieve this, we’re bringing together talent from top technology, service, and healthcare companies to work side by side. Getting pharma and biotech companies to run end-to-end studies with Trialspark will be critical to our mission and success.

Job Description

Our Quality Assurance (QA) team at Trialspark is looking for experienced computer system validation (CSV) professionals that can build our CSV program from the ground up. This role will work closely with QA and the engineering team to validate our systems in accordance to regulatory guidelines and create a change management system.

Your responsibilities will include:

• Building the CSV program and culture at Trialspark
• Education and training to the team on CSV regulatory requirements and how they apply to the team
• Employing CSV methods in an Agile methodology
• Hands-on support of User Acceptance Testing from writing test scripts all the way to summary reports
• Ensure documentation is audit and inspection ready

Relevant Experience

• This is an open-level position so based on your experience we will calibrate on exact title:
  • Associate: 1-3 years of computer system validation experience
  • Manager: 4-8 years of experience
  • Senior Manager: 8-10+ year of experience
• You are scrappy, a fast learner, and not intimidated to roll up your sleeves to get something done
• You have built CSV processes previously
• You have an analytic mind with strategic ability
• You have worked in a cross-functional environment previously
• You have demonstrated strong project management skills
• You are organized, detail-oriented, and focused on getting things done

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.