Job Description

Role Description
This is a contract role for a Clinical Systems Implementation & Validation Engineer. The Engineer will be responsible for working alongside cross functional teams to execute various Computer Systems Validation (CSV) activities, including reviewing and testing computerized systems. Debugging and Silicon Validation will be a part of the role as well. Test cases will be developed and reviewed alongside all teams to ensure it meets the requirements of the organization. This is an on-site role located in Palo Alto, CA.

Responsibilities:
Categorize and implement compliant Computerized Systems using Risk based approach for clinical applications.
- Author and review Change Controls for Clinical applications implementation and upgrades.
- Perform and review release impact assessments to support SaaS vendor releases (BSI and Veeva)
- Develop and review project plans to implement enhancements to clinical systems.
- Develop validation strategies for critical Clinical Systems integrations to ensure the study data availability in CTMS from sites (EDC to CTMS, IRT to CTMS and EDC - IRT uni/bi-directional Integrations).
- Author, review and approve validation documentation deliverables (Validation Plan, User/ Functional Requirements Specifications (URS/ FRS), Functional Risk Assessments, Qualification Plan, Requirement Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) / User Acceptance Testing (UAT), Qualification Report and Validation Summary Report)
- Train Test Script authors and test executors to perform PQ/ UAT executions in Azure DevOps to align with Client Qualification Management SOPs.
- Author Data Migration Plan including migrated data verification methods for archiving CRO eTMF files and audit trial files for closed trials.
- Review and Approve Periodic Review reports and coordinated with vendors to review and document system maintenance activities.
- Review Master Service Agreements and perform gap analysis with client policies and procedures and updated client SOPs to resolve the procedural gaps.
- Perform Root Cause Analysis (RCA) 5 Whys and fishbone methodology for Deviations and implemented Corrective And Preventive Actions (CAPA), Effectiveness Checks and Emergency Changes.
- Act as an IT Scribe for Mock Audits to enable the communication between Front and Back rooms


Required Skillset
This Candidate must have a background in the following
· Clinical Systems Experience (Veeva)
· CSV- CSA is helpful
· EDC (Electronic Data Capture) Veeva System, IRT, CTMS
· Data Management Experience (CRO)
· SOPs
· Systems Integrations Knowledge.
Employment Type: Contractor
Salary: $ 85.00 89.00 Per Hour

Job Tags

Hourly pay, Contract work, For contractors,

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