Clinical Systems Implementation & Validation Engineer Job at LS Solutions, Palo Alto, CA

TWZpb0F6aFVIc1o5NDhDdDRZN1pidkdR
  • LS Solutions
  • Palo Alto, CA

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,

Similar Jobs

CED Systems

Tower Foreman Job at CED Systems

 ...company procedures and safety rules. Read Plans, Site Plan and Tower Drawings. Ability to create rigging plans....  ...stand, use hands to finger/handle/feel, reach with hands and arms, climb or balance, talk or hear. Occasionally the work requires the employee... 

Octagon

Experiential Director (Motorsports) Job at Octagon

 ...position can be flexible with a preference for working in one of our office locations - -...  ...or Atlanta, GA. We will also consider a remote-based working arrangement for qualified candidates...  ...Excel)~ Ability to travel as required- Weekend and Holiday event work are part of the... 

Sunrise Senior Living

Director of Nursing RN Job at Sunrise Senior Living

 ...Care Plan by all team members.Ensures proper follow through and documentation of guest/resident care.Facilitates relationships with Hospice, Therapy, and other providers.Participates in community awareness activities and community relationship development.Assists in... 

University of Minnesota

Research assistant Job at University of Minnesota

 ...students, who will be participating in a research experience for up to two consecutive...  ...location options include working fully remote, partially remote, or entirely in the office...  ...applies for Undergraduate Students, Graduate Assistants, Residents, Fellows and Interns. How To... 

Ahoskie Health and Rehab

Clinical Nurse Specialist Job at Ahoskie Health and Rehab

 ...administrator, to assure that the highest degree of quality care is maintained at all times. Delegation of Authority As the Clinical Nurse Specialist , you are delegated the administrative authority, responsibility, and accountability necessary for carrying out your...