Associate Validator II – Fortrea
Location
Bangalore, India / Remote (India)
Job Type
Full-time (Remote)
Experience Required
3+ years of validation experience in a Global CRO, Pharmaceutical, or Clinical Research organization.
Experience with Electronic Data Capture (EDC) validation and clinical systems is preferred.
Estimated Salary Package (Market Standard)
₹8 – ₹14 LPA (approx.), depending on experience, technical expertise, and interview performance.
Job Overview
The Associate Validator II supports Global EDC Solutions by managing validation documentation, executing validation activities, and ensuring compliance with Quality Management, Good Clinical Practice (GCP), and ICH guidelines. The role involves creating and executing validation test scripts, maintaining controlled documentation, and supporting project teams in validation-related tasks.
Key Responsibilities
Validation & Testing
Create, execute, and document validation test scripts.
Support validation activities for Electronic Data Capture (EDC) systems.
Record and maintain validation test results accurately.
Ensure validation deliverables meet quality standards.
Documentation Management
Manage validation and contractual documentation.
Create, print, track, and maintain study documentation and controlled documents.
Maintain accurate records of all validation activities.
Ensure documentation complies with project requirements and SOPs.
Project Support
Support project teams with validation-related activities.
Prioritize assigned tasks to meet project timelines.
Assist in maintaining validation metrics and reports.
Participate in special projects and process improvement initiatives.
Perform additional duties assigned by management.
Quality & Compliance
Follow Fortrea Standard Operating Procedures (SOPs).
Ensure compliance with Quality Management Systems (QMS), Good Clinical Practice (GCP), and ICH guidelines.
Maintain high levels of accuracy and attention to detail.
Deliver quality work within established timelines.
Educational Qualification
Bachelor's degree in Life Sciences, Health Sciences, Information Technology, or a related discipline.
Certification in an allied health profession is also acceptable.
Equivalent relevant experience may be considered.
Required Skills
Experience with system validation in a CRO or pharmaceutical environment.
Knowledge of Electronic Data Capture (EDC) systems.
Understanding of GCP, ICH guidelines, and Quality Management Systems.
Experience creating and executing validation test scripts.
Strong documentation and record management skills.
Excellent attention to detail and organizational abilities.
Strong written and verbal English communication skills.
Ability to prioritize multiple tasks and meet deadlines.
Teamwork and collaboration skills.
Adaptability to changing technologies and work environments.
Preferred Qualifications
Experience supporting Global EDC Solutions.
Familiarity with clinical trial systems and validation documentation.
Knowledge of controlled document management processes.
Experience working on global clinical research projects.
Work Environment
Fully remote (Home-based) role.
Collaboration with global project teams across different time zones.
Requires effective time management and independent working skills.
Who Should Apply
Validation Specialists, Clinical Systems Validation Associates, EDC Validation Professionals, and Clinical Technology professionals with 3+ years of experience.
Candidates looking to build or advance their careers in Clinical Systems Validation, EDC Solutions, and Clinical Technology within the CRO or pharmaceutical industry.
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