eClinical Business Lead, UAT Lead
P
ParexelClinical Research
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Fluent in written and oral English and local language
- Experience
- 5+ years of experience in clinical research, clinical trial operations, or a related CRO/Pharma setting
- Required Skills
- Project Management
Requirements
- Bachelor's degree level education in life sciences, computer sciences, or equivalent experience.
- 5+ years of experience in clinical research, clinical trial operations, or a related CRO/Pharma setting.
- Proven experience in configuration, delivery, or validation of clinical trial systems (e.g., IRT/RTSM, eCOA, ePRO).
- Prior experience in identifying test case scenarios and knowledge of Good Documentation Practice in electronic testing.
- Knowledge of ICH-GCP, regulatory requirements, 21 CFR Part 11, and clinical trial processes.
- Strong communication, organization, and problem-solving skills with demonstrated ability to learn new systems.
- Fluent in written and oral English and local language.
Responsibilities
- Oversee and manage the delivery of User Acceptance Testing (UAT) of eClinical vendor systems including IRT, eCOA, ePRO, and integrations.
- Input to project plans for UAT deliverables, manage UAT delivery timelines, and be accountable for on-time delivery.
- Interpret clinical protocols and highly technical user requirements documentation to identify suitable test case scenarios and prepare comprehensive test scripts.
- Analyze vendor system requirement specifications and collaborate with all stakeholders to create and review system requirements and integration needs.
- Identify and mitigate risks related to system setup and integration; ensure quality, timeline, and budget alignment with project requirements.
- Serve as the main point of contact for UAT with the project team, vendor, and sponsor.
- Coordinate resources required for UAT delivery and stay current on latest technology offerings and industry developments.
- Train and mentor junior team members and contribute to audit discussions as required.
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