IT Enterprise Architect with Life Science Experience

Overview

Remote
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Enterprise Architect
Life Science

Job Details

Hi ,

This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look.

Job Title: IT Enterprise Architect with Life Science Experience

Location: Boston, MA (Remote)

Duration: 12+ months

Job Description:

The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that supports and accelerates business objectives, emphasizing a commitment to excellence, driving innovation, and ensuring adherence to regulatory standards. The individual in this role will partner with the Head of IT in the development of an overarching IT strategy that integrates business processes, data management, and technology infrastructure, facilitating seamless research, development, and enterprise operations. With a proven background in designing and implementing sophisticated IT architectures in the life sciences sector, the ideal candidate will demonstrate exceptional vision, leadership, and the ability to engage effectively with stakeholders at all levels.

Required Technical Knowledge/Experience/Skills:

  • Strong Pharma/Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes
  • Extensive experience in enterprise architecture within the life sciences industry, with a deep understanding of the unique challenges and opportunities it presents.
  • Deep understanding of pharma related Technology Solutions/Platforms, including but not limited to:
    • PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
  • Proficiency in designing and implementing technology solutions that meet regulatory requirements and support business processes in clinical development and operations.
  • Familiarity with modern data management technologies, cloud computing solutions, and IT platforms specific to the life sciences sector.
  • Strong understanding and working knowledge of:
    • GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
    • Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)
    • Nonclinical Study Data (SEND)
    • Safety Data (ISO/HL7 27953: E2B(r2), E2B(r3); ICSR, PADER, PSUR, DSUR)
  • Experience with software development methodologies and frameworks including Computer System Validation (CSV) process and SDLC, with the ability to guide and influence IT development and governance practices.
  • Strong familiarity with current IT technologies, platforms, and tools, including cloud computing, data analytics, cybersecurity measures, and enterprise software solutions.
  • Deep understanding of and proficiency in various project management methodologies, including Agile, Scrum, Waterfall, and Lean. Experience in working in Agile teams and utilizing Jira.
  • Strong experience in developing cloud architecture with a deep understanding of AWS and Azure Architecture
  • Holds relevant certification (e.g. TOGAF, AWS/Azure Certifications etc.)

Required Work Experience:

  • Advanced degree in computer science, technology, engineering, or related disciplines required.
  • 8+ years pharmaceutical/biotech company or consulting experience required.
  • 5+ years working in an IT enterprise architecture role.
  • Demonstrated success in developing and executing IT architectural strategies in an enterprise and clinical setting.
  • Extensive experience in applying enterprise architecture frameworks (e.g., TOGAF) to develop coherent and scalable IT architectures. Demonstrated ability to establish and enforce architectural standards, guidelines, and best practices across IT projects and systems.
  • A proven track record in navigating the unique challenges and regulatory environments of these sectors is essential.
  • Extensive experience in managing relationships and projects involving heavily outsourced partner/vendor organizations, including Contract Research Organizations (CROs) and Functional Service Providers (FSPs).
  • Demonstrated success in evaluating, selecting, and implementing technology solutions and platforms that address specific business needs within the life sciences industry.
  • Experience design and overseeing the implementation of data platforms and services.
  • Experience in managing technology implementations, including data platforms, cloud solutions, and regulated systems.
  • Hands-on experience in designing and documenting detailed solution architectures for a range of IT projects, including custom-developed applications, data integration platforms, and cloud-based services (IaaS, SaaS, PaaS).
  • Expertise in creating architectural diagrams, blueprints, and models that clearly communicate design decisions and integration points.
  • Experience working with and implementing regulated systems in a GxP regulated industry; Computer Software Validation (CSV), and IT SDLC
  • Advanced degree in computer science, technology, engineering, or related disciplines required.

Thanks & Regards,

Vidhya Sagar

Lead Technical Recruiter | K-Source Inc.|

Website: | 9555 Lebanon Rd, 103 Frisco, TX 75035 |

Email: |

Cell:

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