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.
Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.
As our GCP Auditor, you will perform audits to ensure TrialSpark maintains the highest quality standards in terms of GCP standards and regulations. This will include:
- Organizing, coordinating and performing GCP (Good Clinical Practice) related audits in relation to all GCP regulated activities.
- Audits will include those taking place at TrialSpark HQ/offices/sites, at vendors, licensed/business partners and investigator sites. You will also have responsibility for auditing related to our internal systems and products (CSV).
- Supporting the development and maintenance of Trialspark’s audit strategy and programs in line with GCP and in conjunction with related management functions.
- Supporting the organization in quality management projects, implementation and follow-up of Corrective and Preventive Actions.
- Providing QA guidance in defining audit strategy, scope, report and associated actions. May represent QA in appropriate and assigned task forces.
- Preparing for and/or participating in regulatory health authority inspections as needed. Contributing to further developing Trialspark’s internal Quality Management System (QMS).
- University or Diploma Degree in Medicine, Pharmacy, Life Sciences, or equivalent qualification
- A minimum of 3 years of experience in GCP auditing
- In-depth knowledge of Good Clinical Practice regulations
- Good communication - both orally and in writing
- Open to new challenges, reliable, flexible and able to work independently as well as in a team
- Experience with software tools used in clinical development
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.