The Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV Specialist, Trial Interactive plays a vital role in ensuring that computerized systems are developed, tested, released, and maintained in a validated state.
Responsible for the continued compliance and further expansion of the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division and consulting to other TransPerfect divisions as needed. This includes, but is not limited to, the following areas:
o Software Development Life Cycle
o Commercial off the shelf (COTS) Validation and subsequent 3rd Party Vendor Qualification
o Infrastructure Qualification
o Regulatory Compliance Evaluations
o Validation Package Reviews/Approvals
o Operational Readiness
o Periodic Reviews
o Change Control
o Client-specific Validation Services
Investigate validation specific complaints or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions; provide the formal Client Escalation Report back to the client
Actively maintain and improve colleagues’ awareness of Systems Validation processes, policies, and procedures through training and any other methods
Travel up to 20% domestically and internationally as required
Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor
REQUIRED SKILLS
Experience with study documentation for clinical development
Knowledge of eClinical technologies
Ability to adhere to and abide by the client’s and company’s quality standards
Exceptional problem solving/critical thinking skills and ability to learn new skills quickly
Superior organizational and multi-tasking skills in order to meet commitments and deadlines
Superior written and spoken communication skills in English
Proficiency in Microsoft Office (Word, Excel, Outlook Powerpoint)
REQUIRED EXPERIENCE AND QUALIFICATIONS
Minimum Bachelor’s Degree or its equivalent
Minimum of 2 years of experience in the Life Sciences industry
Minimum of 3 years of experience in the Computerised System Validation
DESIRED SKILLS AND EXPERIENCE
Knowledge of the latest ISO 9001 and ISO 27001 standard
Knowledge of clinical development phases and processes
Knowledge of regulations (e.g. FDA, EMA, MHR) and industry best practices including GxP (e.g. GCP, GMP, GDP), ICH E6 R2, 21 CFR Part 11, Annex 11, GAMP 5.
Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site
Previous experience in CAPA management and root cause investigations
Fluency in a foreign language
Able to multitask in a fast-paced environment
Work well with people from a variety of different backgrounds and cultures
Build relationships with clients and co-workers
Can work independently and as part of a team
DataForce delivers high-quality, multimodal training data and services to power the next generation of AI. From large language models to voice, image, and video generation, DataForce supports AI innovators in tech, life sciences, automotive, and beyond with scalable, secure solutions for development, testing, and safety. Backed by cutting-edge technology and over one million data contributors, DataForce helps ensure AI systems are accurate, adaptable, and ready for real-world deployment.
DataForce is part of TransPerfect, the world’s largest provider of language and AI solutions for global business, with offices in more than 140 cities worldwide. Learn more at www.dataforce.ai.
Contact: dataforce@transperfect.com
