eClinical Business Lead, UAT Lead
New
J
JobgetherClinical Research
IndiaFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 5+ years
- Required Skills
- Project Management
Requirements
- Bachelor’s degree in life sciences, computer science, information technology, or equivalent experience.
- 5+ years of experience in clinical research, clinical trial operations, CRO, pharmaceutical, healthcare, or related regulated environments.
- Proven experience with configuration, delivery, validation, or testing of clinical trial systems such as IRT/RTSM, eCOA, or ePRO.
- Experience creating test case scenarios, test scripts, and managing User Acceptance Testing activities.
- Knowledge of Good Documentation Practices (GDP) and electronic testing processes.
- Understanding of ICH-GCP, regulatory requirements, 21 CFR Part 11, and clinical trial processes.
- Strong project management, communication, organization, and problem-solving skills.
- Ability to independently manage multiple priorities and lead meetings effectively.
- Fluent written and verbal English communication skills.
Responsibilities
- Lead and manage UAT delivery for eClinical vendor systems, including IRT/RTSM, eCOA, ePRO, and system integrations.
- Define UAT plans, manage timelines, and ensure testing deliverables are completed according to project requirements.
- Review clinical protocols and technical documentation to identify appropriate test scenarios and create comprehensive test scripts.
- Analyze system requirements and collaborate with stakeholders to validate configurations and integration needs.
- Identify risks related to system setup, integrations, quality, timelines, and project delivery, implementing mitigation strategies when needed.
- Act as the primary UAT contact for project teams, vendors, and sponsors, maintaining strong stakeholder relationships.
- Coordinate testing resources, including testers and technical quality teams, to support successful execution.
- Support audit activities and maintain compliance with clinical research standards and documentation requirements.
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