GCP & CSV Auditor

| Greater NYC Area

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.

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.

Job Description

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).

Relevant Experience

  • 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.

Read Full Job Description

Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases

Location

Our office is located in the Flatiron District of NYC, near Madison Square Park. The area is lively and has great food and transportation options!

An Insider's view of TrialSpark

What are some social events your company does?

We believe in healthy living! We organize regular team exercise classes as a company!

Frank Wu

Product Manager

How do you empower your team to be more creative?

We believe in presenting problems, not solutions, to the team. Our job is to align the team on company goals and issues, and allow the team to work creatively to solve them. We believe team autonomy fosters creativity and a healthier culture.

Linhao Zhang

CTO

What are TrialSpark Perks + Benefits

TrialSpark Benefits Overview

Trialspark is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
We have a monthly transportation subsidy!
Company Outings
Yearly retreat and holiday party, regular team events and outings!
Free Daily Meals
We offer free lunch every day except Wednesday (when we encourage employees to leave the office and explore the area!)
Game Room
Super Smash Club every Friday!
Stocked Kitchen
Happy Hours
Pet Friendly
Come meet our office dog, Rosie!
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
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