Senior System Analyst R&D (Veeva) (Citrus Heights)

Foothills Consulting Group in Citrus Heights, CA

  • Industry: Healthcare - Allied Health - Medical Technologist (MLS)
  • Type: Full Time
position filled

We are seeking a Sr System Analyst (R&D) for a contract to hire opportunity with our client located in Orange County California.

Manage the configuration of systems (mainly Veeva eTMF, CTMS and CDMS) in support of some new clinical studies planned to start in 2020

The Sr. System Analyst (R&D) will serve as a technical expert in delivering IT systems and providing system operational support for our client's R&D related business functions. The primary focus will be on collecting, documenting and analyzing requirements, evaluating architecture and design, implementing and qualifying technology solutions, executing change controls, and maintaining systems.

The position will be responsible for IT system management for Client's Clinical Operations, Clinical Research, and Clinical Data Management business functions.

Successful candidates are expected to have technical expertise, knowledge and hands-on experience supporting IT capabilities and systems for the Clinical Development division of companies within the pharmaceutical, biotech or medical devices industries. In addition, the candidate will have demonstrated experience working with cross-functional services groups, including IT, Quality Assurance, Project Management, to ensure successful business alignment, application integration, solution delivery, technology architecture, GxP compliance, system maintenance & operational support, and IT security that meet or exceed the quality standards and compliance requirements expected within the pharmaceutical industry.

Act as a technical lead and participate in projects/programs to drive the delivery of technology solutions for the Clinical Development business function.

The primary focus will be setting up and maintaining clinical studies in different clinical systems in our eClinical Platform. Contribute to user requirements specification, design specification, system and business configuration, system build, validation plan and report, test scripts development and execution, technical manuals, user training, system release to production and transition to operation. A good candidate will demonstrate strong hands-on experience and technical expertise in the following areas:

SKILLS:

  • Participate in the project initiation process. Understand business process modeling techniques; Develop concept/domain model, process flow and data flow diagrams; Collect and document business needs, use cases and requirements. Develop User Requirements Specification.
  • Architecture and Design: Have a very good understanding of enterprise architecture and system design principles. Able to propose or evaluate design options including design elements related to UI/UX, System Integration, Data Reporting, etc. based on industry standards and best practices. Develop Configuration or Design Specification.
  • Implementation: Lead the delivery of technology solutions per business requirements. Coordinate effort to resolve technical issues and ensure the system meets the intended use, with quality and efficiency.
  • Testing and Validation: Have an excellent understanding of GxP Requirements related to Computer Systems, including 21 CFR Part 11 and Annex 11. Participate in risk and impact analysis of new systems or components to business processes/operations, and changes to existing systems or components according to the client's policies & procedures, and regulatory compliance requirements. Develop Validation Plan and IOPQ Test Scripts, perform Testing and create Validation Summary Report.
  • Release: Create technical manuals, training materials, provide user training. Transfer knowledge and transition system to operation team and transition. Support both system platform upgrade and study build. Prepare release memo and communication.
  • Operation: Work with internal & external groups to manage the overall clinical systems maintenance and operational support. Coordinate effort, and engage appropriate stakeholders, users and vendor staff to manage system maintenance needs, product releases, service requests, incidents, problems, and change controls.
  • Communicate effectively with supervisors, peers, project managers, and stakeholders.
  • Must have a strong work ethic, trust, integrity, and accountability.

REQUIREMENTS:

  • Bachelor s degree in Information Technology, Engineering or related scientific, technical or business field.
  • 5-10 years of relevant work experience in an Information Technology role, including 3-5 years in pharmaceutical/biotech/medical devices industry supporting Clinical Development IT systems.
  • Strong interpersonal, analytical and problem-solving skills. Excellent written and verbal communication skills.
  • Exceptional customer service focus and perspective. Must be well organized, flexible and responsive with the ability to handle multiple tasks simultaneously.
  • Experience with System Development Life Cycle (SDLC) and GxP Computer System Validation (CSV), including a thorough understanding of risk-based validation and change management.
  • Experience supporting core Clinical IT systems (eSource, eCOA, eConsent, EDC/CDMS, IWRS/IVRS, CTMS, eTMF, ePayment, eSurveillance and Risk-Based Monitoring, etc.), especially Veeva Vault Clinical Suite Products.
  • Experience with Platform as a Service (PaaS) and Software as a Service (SaaS) is strongly recommended.
  • Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.).
  • Core competencies for this role include: Adapt to Change demonstrate Organizational Awareness, Self-Awareness, Proactivity, and Learning Agility
  • Work Collaboratively embody Teamwork, influence without authority, and demonstrate Technical Expertise
  • Apply Judgment effectively leverage Prioritization, Problem Solving, and Decision-Making skills to achieve superior results
- provided by Dice
Associated topics: blood collection, mlt, pathology, sample collection, sterile processing technician, surgical technologist, technician, technician ii, technician iv, technologist

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