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IT GxP / Veeva System Administrator and Business Analyst

Redwood City, CA · Biotech/Pharmaceutical
Title: IT GxP / Veeva System Administrator and Business Analyst

Type of role: Contract or Contract to Hire – Remote

Location of client: Redwood City, CA
 
*****Candidate must have previous experience with Veeva and must have worked in a Pharmaceutical and or Biotech environment*****
 
IT GxP / Veeva Systems Administrator and Business Analyst will collaborate with internal (QA) and external (Veeva etc.) stakeholders to translate business functional requirements into IT solutions including basic project management, system implementation, Validation, training and act as subject matter expert on Veeva to the business. Also supporting & promoting IT new processes and business system as details below
  • Veeva Clinical Operation eTMF and Veeva Regulatory RIM system implementation as System Admin and Business Admin Role.  Activities such as supporting Production Go-Live; Veeva Quadrimester System Release and Phase 2 Data Migration project activities. On-going business functional requirement requests, change management and communication. Annual GxP System Periodic Review activities and documentation.
  • On the GxP DocuSign Part 11 system, consultant will be working closely with a third party to create and administration user SOPs and training. Act as DocuSign Part 11 SME. Able to support on-hand training sessions, monthly user communities’ sessions on issues and enhancement request.  Support Validation activities and Monthly Release impact assessment & change management.
  • On the Box & GxP Box File Shared migration project, this role will work closely with all business unit stakeholder, to support project implementation.  GxP Box System Administrator to follow procedures and documentation of user roles and security setup.  Periodic review and full fill system audit request.
  • For the IT System Process and Procedures, this role will be supporting IT Management to develop and promote the new and enhance Processes with Policies, Procedures and Forms.
Education:
• BS/BA degree in related discipline and four years of related experience;
• Degree in computer science, information systems, business administration or
   other related field (or equivalent work experience).
• Veeva Foundation and eTMF or RIM module certification a plus.
• Computer System Validation & GxP Part 11 experience is required.
• Experience in strategic information system development for research and
   clinical organizations.
 
Experience:
• A minimum of 5 years experience in Pharma or Biotech.
• At least 2 years’ experience in Veeva.
• Experience demonstrating application of the software development life cycle
   (SDLC), Information Technology Infrastructure Library (ITIL), change
   management and capacity planning best practices.
• Experienced in multiple information technology systems and areas, including
   various cloud system. (e.g., Veeva eTMF, RIM, ERP, CRM, DocuSign, SharePoint, OneDrive, Box).
• Practical experience and knowledge managing systems in a regulated
   environment.
 
Knowledge/Skills/Abilities:
• Motivating and orchestrating high performing vendor cooperative teams.
• Solutions focused critical thinking with a succeed together attitude
• Developing high quality solutions, processes, and support.
• Applies strong analytical and business communication skills, both verbally and in
   writing.
• Must have previous experience in Pharma and or Biotech.
• Develop technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures, and evaluation
   criteria to achieve results.
• Guides the successful completion of major programs, projects, and/or functions.
• Determines organizational or team objectives and interprets company policies.
• Has complete understanding and wide application of technical principles,
   theories, concepts, and techniques.
 
Dawn West
AdeptSource
 

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