Systems Test Engineer

India

Job Description:

Conduct day-to-day software quality assignments of internal and out-sourced software development activities for all clinical trial operations within the company.  Identifies and resolves problems as they arise.  This role is characterized by the responsibilities of an individual who may interact with Project Managers, operations staff, Business Analysts, Systems Developers, and management.  Requires minimum supervision and ongoing training to assure consistent performance. The Systems Test Engineer shall be very detail-oriented, possess good documentation skills, and be a self-starter.  Will be capable of collaborating with stakeholders to identify, isolate, and resolve defects found during all phases of the systems product’s test cycle.  Shall demonstrate consistent and cooperative service in support of staff, co-workers, and sponsor personnel.  Must exhibit and maintain a team approach and a positive attitude.  Shall maintain a current working knowledge of industry regulations supporting e-clinical trials.

Responsibilities & Accountabilities:

  • Support the development of detailed User Requirement Specifications or Project Specifications, and Functional and Design Specifications as applicable.
  • Responsible for developing detailed validation plans to cover the testing strategy, intended use of application, validation and functional risks, and the planned validation activities.
  • Responsible for creating test cases and scripts to adequately verify that the software is performing as intended.
  • Responsible for creating Requirements Traceability Matrixes to ensure that all requirements have been adequately tested.
  • Responsible for developing detailed validation reports covering the results of the validation activities and any issues identified.
  • Effectively manage the issue tracking system.
  • Ensure that issues are documented and resolved in the issue tracking system in a timely manner.
  • Responsible for ensuring that software applications are developed and deployed with the ability to comply with 21 CFR Part 11, Electronic Records; Electronic Signature and Annex 11: Computerized Systems, EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, GMP Medicinal Products for Human and Veterinary Use.
  • Coordinates procedural or system changes with the Head of Q/RA, who has oversight of this function for Regulatory compliance, to improve the effectiveness of the quality assurance system.

Education & Experience:

Basic requirements:

  • Minimum of bachelor’s degree, preferably in Business Information Systems, Engineering or Computer Science
  • 2+ years of experience in a business systems analyst role related to clinical data management in a CRO or pharmaceutical industry preferred
  • Strong project management, written and verbal communication and organizational skills
  • Initiative-taking individual with strong interpersonal skills
  • Understanding of different therapeutic areas (e.g., RECIST 1.1, Rano; EAC) preferred
  • Ability to manage multiple priorities and handle multiple projects simultaneously
  • Ability to troubleshoot problems quickly and effectively and escalate where needed
  • Desired qualifications:
  • Knowledge of clinical trial management
  • Knowledge of software guidance within GxP/FDA regulated industry

Candidates can send their CV to hr@voiantclinical.com. Please feel free to reach out to HR Talent & Culture with any questions.