Validation Specialist I

☞ Novotech Asia

View: 104

Update day: 28-05-2024

Location: Bengaluru / Bangalore Karnataka

Category: Electrical / Electronics Pharmacist / Pharmaceutical representatives

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Job content

Brief Position Description:

The Validation Specialist I (VS I) is responsible for validation activities of Clinical Data Management (CDM) software systems - especially EDC systems - configured and used for capturing clinical data and third-party data. The VS I work closely with the Technical Design and Clinical Data Programming teams in undertaking the specification, execution and completion of validation tasks.

Minimum Qualifications & Experience:

Graduate in computer science, IT or life science related field, or similar. More than two years of experience in a Clinical Data Programmer/Validation role in a pharmaceutical company, CRO or EDC software provider. Knowledge of regulatory validation requirements with respect to clinical systems and study databases.

Responsibilities

The Validation Specialist I (VS I) is responsible for undertaking all validation tasks across multiple projects in accordance with applicable SOPs, and best practices.

1. Project/Clinical Studies

  • Create Validation Plans for the EDC study DB and related software applications and create other study test plans as required per protocol (e.g., interfacing to third party application).
  • Create Edit Check test plans and liaise with Clinical Data Programmer and Data Analyst as to the number and nature of edit checks to be implemented in the EDC study DB versus other software tools.
  • Undertake all validation and testing activities, document test results and communicate to relevant stakeholders including Clinical Data Programmer, Technical Designer and Clinical Data Manager. Update validation and test plans as required and re-test until all tests have passed and documented.

    2. Validation Team
  • Participate in Validation team and Biometrics department meetings.

    3. Software Tools
  • Ensure proficiency with the company’s EDC systems that are used for designing electronic CRFs and edit checks.

    4. Validation Processes and SOPs
  • Adhere to SOPs and best practices instructions and templates related to validation activities.
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Deadline: 12-07-2024

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