Remote - India

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, 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.

- Performs other departmental or study-related duties as assigned.

Education &

- Experience

- Bachelor’s degree in computer science with 4 years of experience in software testing or equivalent

- Ability to understand clinical protocols and criteria. Preferably have 1 year experience in clinical research or healthcare

- Relational database design and development experience

- Programing experience in JSON, Python

- Ability to organize and manage multiple priorities; work in fast-paced setting.

- Excellent verbal/written communication skills in the English language and attention to detail

- Analytical and creative problem-solving skills for design, creation and testing of systems.

- Experience working with databases such as postgreSQL

- Experience working with Windows Operating Systems

Candidates can send their CV to [email protected]. Please feel free to reach out to HR Talent &
- Culture with any questions.

📌 Systems Test Engineer (Itanagar)
🏢 WorldCare Clinical (now Voiant)
📍 Itanagar