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 & take 10 years to complete, bottlenecking the development of new treatments for patients.
Our company is using software & technology to streamline all aspects of a clinical trial. By reducing the time & 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 & regulations. This will include:
- Organizing, coordinating & 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 & investigator sites. You will also have responsibility for auditing related to our internal systems & products (CSV).
- Supporting the development & maintenance of Trialsparks audit strategy & programs in line with GCP & in conjunction with related management functions.
- Supporting the organization in quality management projects, implementation & follow-up of Corrective & Preventive Actions.
- Providing QA guidance in defining audit strategy, scope, report & associated actions. May represent QA in appropriate & assigned task forces.
- Preparing for and/or participating in regulatory health authority inspections as needed. Contributing to further developing Trialsparks 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 & in writing
- Open to new challenges, reliable, flexible & 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.