Worldwide Clinical Trials Company Profile

Solutions Engineer

Worldwide Clinical Trials

Munkaköri leírás

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

SUMMARY: Implement, configure, and maintain systems used in the management and conduct of clinical trials to meet business and technical or study specifications by contributing at all stages of the software development life cycle.

RESPONSIBILITIES:

  • Ensure production systems are functioning to meet their service level agreements by analyzing and resolving issues encountered, including the implementation of bug fixes where required and in alignment with SOPs
  • Implement software solutions to meet study requirements, including but not limited to data integration, monitoring and reporting using a variety of platforms, tools, and languages
  • Support the Clinical Systems Project Manager and other job functions with the production and review of specifications, plans, reports, study materials and other documentation during the development and support of systems
  • Review User Requirements Specifications as appropriate
  • Prepare, review and approve study design and integration documentation
  • Perform coding and configuration to meet study timelines, fulfill business and technical requirements, and align with SOPs
  • Perform formal code reviews to meet study timelines
  • Perform informal unit testing to meet study timelines
  • Complete Traceability Matrices as required
  • Work closely with applicable Worldwide departments to define and coordinate integration processes between systems/vendors
  • Interact and effectively communicate with project teams on technical and non-technical terms to determine test and code/configure requirements and acceptance criteria
  • Write and execute scripts as required to meet study timelines
  • Support Test Analysts during formal testing and/or quality review
  • Perform QC checks of manual database edits and other tasks where required
  • Assist in the investigation and resolution of issues and/or incidents
  • Ensure that all activities are appropriately documented and stored in accordance with the relevant SOP and requirements of the client company
  • Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
  • Provide support for users of in-house software.

OTHER SKILLS AND ABILITIES:

  • Ability to communicate concisely and effectively in both written and spoken English
  • Proficient in the use of common office software
  • Able to work independently or in a multi-disciplinary team
  • High attention to detail
  • Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems

REQUIREMENTS:

  • Educated to degree level in a relevant discipline or be able to demonstrate equivalent experience
  • Have a sound working knowledge of at least one of the following: Java and Java Server technologies; Bus integration technologies; UNIX including C, C++ ; relational databases; or the Microsoft toolset including .Net Framework 4.5 , C#, Visual Studio
  • 2+ years’ experience in a combination of Contract Research Organization (CRO) experience, IRT study delivery, or clinical systems development desired
  • Familiarity with clinical trials, patient safety, data integrity and associated regulations desired
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