Parexel
Website:
parexel.com
Company:
https://www.linkedin.com/company/parexel
Seniority: Not Applicable
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care
Job details:
We are seeking an eClinical Business Lead/UAT Lead (User Acceptance Testing Lead) to join our team. As an eClinical Business Lead/UAT Lead, you will oversee and manage the delivery of User Acceptance Testing for eClinical vendor systems including IRT (Interactive Response Technology), eCOA (electronic Clinician-Observed Assessment), ePRO (electronic Patient-Reported Outcome), and system integrations. This position plays a key role in ensuring clinical trial technology solutions meet project requirements, regulatory compliance standards, and sponsor expectations. You'll collaborate with cross-functional teams, vendors, and external clients to deliver robust, validated technology platforms that support study execution and patient safety. Responsibilities include managing UAT deliverables, creating and executing comprehensive test scenarios, and ensuring quality and timeline adherence from planning through closeout.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic technology delivery, stakeholder collaboration, and continuous improvement in clinical trial operations. With diverse teams and continuous learning opportunities, the eClinical Business Lead/UAT Lead can explore career paths and expand skills across clinical research technology, vendor management, and clinical operations.
Key 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, ensuring project team satisfaction and maintaining excellent customer relationships
- Coordinate resources required for UAT delivery (e.g., testers, technical quality managers) and stay current on latest Parexel technology offerings and industry developments
- Train and mentor junior team members and contribute to audit discussions as required
- Be accountable for all technology setup for assigned trials and ensure work is captured correctly in project budgets
You'll Thrive In This Role If You Bring
- Strengths in technical communication, project management, and stakeholder coordination
- Experience working in clinical research, healthcare, or a regulated environment
- The ability to collaborate across teams and communicate clearly at all levels
- A patient-focused mindset and strong attention to detail
- Comfortable working with eClinical systems, clinical trial technology platforms, and software testing methodologies.
- Proven ability to independently manage competing priorities and lead meetings effectively
Required Qualifications
- 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
Preferred Qualifications
- Experience in IRT, eCOA, or ePRO design, testing, or delivery
- Knowledge or experience with data standards such as CDISC SDTM
- Experience mentoring team members and providing day-to-day work direction and guidance
- Awareness or experience in the needs and use of data standards in clinical trial environments
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be perfect fit, send them the link to apply!
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