Senior Associate – Senior Central Testing Analyst
Location: Chennai, India
Category: Clinical Data Management / Medical
Job Type: Full-Time
Job ID: 4943977
About the Role
As part of Clinical Data Sciences, a key unit within Clinical Development & Operations (CD&O), the Senior Central Testing Analyst plays a pivotal role in ensuring the integrity, accuracy, and compliance of clinical trial databases. This role leads database testing and validation (UAT) at the study or asset level, ensuring Case Report Forms (CRFs) are designed per protocol and end-users can enter data effectively. The analyst is also responsible for edit check verification, data specification validation, and providing clinical/technical feedback to optimize database performance.
Key Responsibilities
Lead database design and UAT activities, ensuring CRFs and edit checks align with protocol requirements.
Perform testing and validation of clinical trial databases, including external electronic data, lab data, and PK/PD data.
Review Study Data Specifications (SDS) and execute screen UAT to ensure accurate capture of Schedule of Assessments.
Write and execute UAT test scripts, log issues in trackers, and provide actionable feedback to study teams.
Participate in data management meetings, providing input on database design, CRF development, and edit check specifications.
Perform peer reviews on programming of edit checks and metadata listings.
Validate manual queries and listings, ensuring consistency with standards and therapeutic requirements.
Track postproduction changes in databases during study conduct and provide clinical/technical recommendations.
Document all testing activities, generate reports, and maintain study documentation for compliance and audit readiness.
Collaborate with global study teams to meet project timelines, quality expectations, and customer satisfaction goals.
Support knowledge sharing, lessons learned, and continuous process improvements across the team.
Qualifications & Skills
Bachelor’s degree in Life Sciences, Computer Science, or related field (required).
Minimum 7 years of relevant experience in clinical data management, database testing, or UAT leadership.
Strong knowledge of clinical development processes, GCP, ICH, GCDMP, and regulatory requirements.
Experience with commercial clinical data management systems/EDC platforms (Inform preferred).
Familiarity with data visualization tools such as Spotfire or J-Review is advantageous.
Working knowledge of MedDRA and WHO-Drug coding.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Strong communication, collaboration, and project management skills, including resource management, timelines, and quality control.
Ability to lead or mentor UAT testing teams, resolving conflicts and communicating effectively with stakeholders.
Work Location & Environment
Hybrid work model: Combination of on-site and remote work.
Collaborative, global clinical data team supporting pharmaceutical and biotech development.
Why Join
This role provides an opportunity to drive quality and compliance in clinical trials, influence database design and validation processes, and collaborate with international clinical teams. You will gain exposure to complex trial data, regulatory frameworks, and cutting-edge data management technologies.
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