UAT Tester at Endpoint Clinical

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field
2–5 years of experience in User Acceptance Testing or Validation of Clinical Trial systems, ideally RTSM/IWRS/IRT platforms
Familiarity with clinical trial processes, ICH-GCP, and regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11)
Strong understanding of subject randomization and drug supply strategies
Detail-oriented with excellent documentation, troubleshooting, and communication skills
Proficient in defect tracking and test management tools (e.g., JIRA, SpiraTeam, Azure DevOps)
Ability to meet deadlines and work under pressure
Demonstrates flexibility and adaptability to shift gears according to the priority of tasks
Possesses a high degree of flexibility, accountability, and responsibility
Capacity to work independently once given adequate instructions
Proficient verbal and written communication skills; willingness to share and receive information and ideas from all levels of the organization
Commitment to the successful achievement of team and organizational goals through participation and helping team members
Strong collaboration and development skills
Proactive team player enthusiastic with high work ethics

Responsibilities

Collaborate with sponsor stakeholders and project teams to define UAT scope, scenarios, and acceptance criteria
Develop UAT test plans, scripts, and data based on functional requirements and study protocols
Execute test cases, document results, and track defects to closure in coordination with the sponsor and internal stakeholders
Validate randomization schemes, drug supply logic, visit schedules, and site management features specific to the RTSM system
Participate in UAT readiness and kick-off meetings, walkthroughs, and test script reviews
Ensure system behavior aligns with end-user expectations across diverse use cases including subject enrollment, kit management, unblinding, resupply triggers, and shipment tracking
Maintain clear and audit-ready UAT documentation, including traceability matrices, deviation logs, and summary reports
Support study teams during go-live readiness activities and contribute to lessons learned for future system deployments
Work closely with Quality, Trust and Compliance team to ensure testing adheres to applicable SOPs, validation standards, and regulatory guidelines

Skills

UAT Testing

RTSM Systems

GxP Compliance

21 CFR Part 11

Test Planning

Test Scripts

Defect Tracking

Randomization Schemes

Trial Supply Management

Traceability Matrices

Clinical Trials

Endpoint Clinical

Provides interactive response technology for clinical trials

About Endpoint Clinical

Endpoint Clinical provides interactive response technology (IRT) systems designed for clinical trials. Their systems assist with various trial processes such as managing drug supplies, randomizing patients, and scheduling visits. These systems are user-friendly and cater to clients in the life sciences sector, including pharmaceutical and biotechnology companies. Endpoint Clinical differentiates itself by focusing on ease of use and integration with other clinical trial management systems, ensuring that clients can streamline their processes and maintain regulatory compliance. The company's goal is to enhance the efficiency and transparency of clinical trials, allowing sponsors to conduct their research more effectively.

San Francisco, CaliforniaHeadquarters

2009Year Founded

$1.7MTotal Funding

DEBTCompany Stage

Enterprise Software, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Risks

Emerging IRT providers with cost-effective solutions threaten Endpoint Clinical's market share.

Rapid AI advancements may outpace Endpoint Clinical's current technology offerings.

Decentralized trials could reduce demand for traditional IRT systems, impacting Endpoint's model.

Differentiation

Endpoint Clinical offers user-friendly IRT systems for clinical trial management.

The company specializes in drug supply management, patient randomization, and visit scheduling.

Endpoint Clinical collaborates with THREAD and Berlinger for integrated clinical trial solutions.

Upsides

Increased adoption of DCTs boosts demand for flexible IRT systems like Endpoint Clinical's.

AI integration in clinical trials offers Endpoint opportunities for advanced analytics.

Personalized medicine trends require sophisticated IRT solutions, benefiting Endpoint Clinical.

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