GCP & CSV Auditor
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 and CSV Auditor, you will perform audits to ensure TrialSpark maintains the highest quality standards in terms of both GCP and CSV standards and regulations. This will include:
- Organizing, coordinating and performing CSV (Computer System Validation) and GCP (Good Clinical Practice) related audits in relation to all CSV and GCP 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.
- Supporting the development and maintenance Trialspark’s audit strategy and programs in line with CSV/ 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 and CSV/GCP 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 CSV and GCP 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/CSV 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.