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Systems Analyst, IM Clinical Systems

SUMMARY

This role will work with our Clinical functions to implement sustainable fit-for-purpose IT capabilities and deliver a high level of reliability and responsiveness in daily IT operations.    Scope includes current and future IT capabilities including but not limited to internal and external systems, solutions, platforms, applications, data management, integrations, process, services and procedures.   Key responsibilities include:

  • Management of the build and run of Clinical IT solutions and services as assigned
  • Consult and advise on direction of IT capabilities in alignment with IT architecture, IT vision and Research needs
  • Assist the IM Associate Director in the development of the Clinical IT roadmap in alignment with IT capabilities
  • Author requirements, use cases, process flow documents with business stakeholders, and execute on implementation plans through rollout and operations
  • Drive quality and scalability in IT business systems, and ensure efficient and effective operational IT processes that adapt to the dynamics of the business
  • Ensure all IT services meet expectations and align to best practices in IT architecture, IT security, GxP compliance, and IT production operations. 
  • Assist in the delivery of new solutions and system enhancements
  • Enable the business to achieve their objectives through the effective use of technology

For new systems implementation, assist in the execution of the IT software development life-cycle including:

  • Provide input into business case development,
  • Actively participate in solution evaluation and selection,
  • Author requirements, business process and data mapping documentation,
  • Create technical requirement documentation, including systems configuration/design specifications
  • Drive technical implementation, related integrations and systems testing,
  • Assist with user training
  • Manage technical components of production roll-out. 
  • Ensure systems are fit-for-purpose for our business processes,

For existing systems:

  • Serve as point of contact for system enhancement requests
  • Serve as the initial point of escalation from help desk for Clinical system issues.

 

KEY RESPONSIBILITIES

  1. Requirements (30%) - Create and own business and technical requirements using interviews, wireframes, storyboards, document analysis, requirements workshops, business process design, prototyping, visual mock-ups, etc.   Assist business partners and IT leadership in identifying options, scope and prioritization that satisfy needs including cost, resource, timeline and direction of IT architecture. 
  • Create visual illustrations to represent proposed solutions during concept phase.
  • Create wire-frame based requirements documents and subsequent mock-ups to outline technology solutions.
  • Support and contribute to creative experience design for user interfaces. 
  • Provide input into business cases,
  • Produce formal requirements documents (including conceptual illustrations), high level technology designs, and required operational support documentation.
  1. IT Delivery (40%) – Implement IT capabilities (on premise and cloud) and related business processes.   Lead Pilots for new solutions to determine fit-for-purpose.   Own change management for new solutions or enhancements
  2. IT Operations (30%) – Own and provide hands-on IT operational support (technology, out-of-the-box configurations, process and content) for installed solutions.  Responsible for maintenance of systems documentation, and adherence to IT Policies, SOPs, compliance standards, GxP requirements (where applicable) and change controls. Provide technical consulting and perform user training with Business System Owner as needed. 
  3. Other duties as assigned by IT management in support of rapidly growing company.

 

QUALIFICATIONS & EXPERIENCE

  • Bachelor’s Degree in Computer Science/Information Systems related or equivalent experience
  • 8+ years hands on experience with GxP and regulated systems, including execution of IT computer systems validation deliverables and process
  • Demonstrated experience in business analysis, IT SDLC, change control, systems implementation, enhancement and operations, and project management methodologies
  • Proven ability to manage multiple, complex activities simultaneously.
  • Strong process design experience to shape business process and best practices.
  • Strong process mapping ability, and ability to see the big picture
  • Experience with Cloud based software applications, packaged application, platform implementations, or custom development
  • Ability to recommend solutions to solve complex problems that start small, and can rapidly scale
  • Previous experience (administration, configuration, master-data management, etc.) with any or all of IT Systems in support of Clinical:  LIMS, eTMF, CTMS, Document Management, External Partner Data Integration
  • High energy, confident, gets things done, yet easy going personality
  • IT Security for software and applications, especially related to external data integration and cloud-based implementations.
  • Experience with rapidly growing academically oriented early phase biotech company a plus
  • Ability to wear multiple hats, and sort-out complex business problems with ease
  • Ability to communicate with individuals and groups about their needs, identify essential requirements and implement solutions.
  • Demonstrated hands-on experience creating project deliverables (business requirements, functional requirements, process maps, test plans, and test scripts).
  • Ability to interact effectively as individual contributor or as a member of a team.
  • Able to work in a fast paced deadline driven environment.
  • Hands on experience in creating visually driven requirements documents.
  • Work on complex and abstract problems independently where decisions are based upon a mixture of analysis, wisdom, experience, judgment and rigorous logic and methods.
  • Meet deadlines and deliver quality work, even under pressure.
  • Global IT experience desired

               

                                                               

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