Computer System Validation Lead – Clinical Informatics
Domain: HealthTech, HighTech
Career Path: RTech, DataBridge, AgileData, Connect
Type: Full Time preferred
Seniority: Mid senior level
Location: Boston
Proven experience in leading sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure. Broad understanding of Technology implementation (SaaS) and Data migrations approaches.
Working knowledge of CSV, data integrity and ICH guidance related to the use of computerized systems in clinical trials
Solid PM skills
Experience with Veeva platforms is a major plus
Extensive hands on work with Validating GxP platforms such as RIM, QMS, SAS
High level experience with RIM processes
Experience supporting regulatory inspections related to computerized systems
Excellent communication skills
Demonstrable experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches
Experience with paperless validation preferred
Bachelor’s degree in computer science, biotechnology engineering or equivalent
EducationBachelor’s degree in computer science, biotechnology engineering or equivalent
Experience10+ years of computerized system validation experience with a primary focus on GCP, GVP and GLP.
5+ years of validation team leadership providing coaching and mentoring to CSV engineers/tech writers and coordinating validation efforts within larger project
DescriptionAs a validation strategist you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory and safety applications.
Essential Duties & ResponsibilitiesDefine overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with QA policies.
Author key validation documents: Validation Plans, Validation Summary reports, Test Plans etc…
Advise project and technology teams on validation and data integrity best practices and approaches
Collaborate with GCP QA on process definition and improvement, author and revise CSV related SOPs
Coordinate with external Vendors on Validation and general IT operations support tasks
Coordinate CSV activities (UAT, document reviews) for clinical digital projects
Liaise with GMP CSV team to harmonize and streamline validation practices
Provide training on validation process and templates
Oversee CSV readiness for inspections and audits, support QA and business team during inspection activities
Computer System Validation Lead – Clinical Informatics
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