Job Title: Senior Associate, Senior Central Testing Analyst
Location: India – Chennai
Job Type: Full-time
Posted: 30+ Days Ago
Job ID: 4943977
Function: Clinical Data Sciences (CDS), Clinical Development & Operations (CD&O)
Department: Pfizer Research & Development
Work Location Assignment: Hybrid
The Senior Central Testing Analyst is a key member of the Clinical Data Sciences group within Clinical Development & Operations (CD&O), responsible for leading database testing and validation activities at the study or asset level. This includes conducting User Acceptance Testing (UAT) for databases, verifying Case Report Form (CRF) design, and ensuring alignment with study protocols. The role also involves testing data specifications to confirm the accuracy and adequacy of edit checks, supporting data quality and compliance with Pfizer’s global standards.
Lead and perform database UAT to ensure CRFs are designed per study protocol and user requirements.
Execute test scripts based on Study Data Specifications (SDS) and Edit Check Specifications (ECS).
Log UAT issues, provide feedback to study teams, and track issue resolution in collaboration with Clinical Data Scientists (CDS).
Review edit check specifications and perform peer review of edit check programming when required.
Compare protocol schedules of assessment with database configuration and provide improvement suggestions.
Test data specifications to verify correct implementation of programmed checks.
Validate manual queries, data listings, and metadata consistency across studies.
Perform validation of reports and document test results as per SOPs.
Identify and suggest improvements in post-production database changes.
Ensure all deliverables meet Pfizer’s quality standards, timelines, and documentation requirements.
Collaborate with Clinical Data Scientists and study teams to understand expectations, timelines, and database requirements.
Participate in UAT feedback meetings and provide clear communication regarding test results and proposed database changes.
Maintain strong relationships with global stakeholders, supporting effective resolution of testing-related issues.
Share lessons learned and contribute to process improvements across projects.
Ensure testing activities comply with Good Clinical Practice (GCP), GCDMP, and Pfizer SOPs.
Standardize test scripts and validation processes across therapeutic areas and study types.
Maintain complete, accurate documentation of testing processes and results.
Contribute to continuous improvement initiatives within the Clinical Data Sciences organization.
Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, or related discipline (minimum requirement).
Minimum 7 years of relevant experience in clinical data management, database testing, or validation within a pharmaceutical, biotech, or CRO environment.
Proven experience in database UAT, including authoring and executing test scripts and managing UAT activities.
Experience leading or mentoring teams in testing processes preferred.
Strong knowledge of clinical data management systems (e.g., Oracle InForm, Medidata Rave).
Proficiency in Microsoft Office tools (Word, Excel, Outlook).
Familiarity with data visualization tools (e.g., Spotfire, J-Review) preferred.
Understanding of MedDRA and WHO-Drug coding standards.
Working knowledge of clinical research regulations (FDA, ICH, GCP, GCDMP).
Strong analytical and problem-solving abilities.
Excellent verbal and written communication skills.
Ability to collaborate effectively in a global, cross-functional, and virtual environment.
Skilled in prioritization, resource management, and meeting deadlines.
Detail-oriented with a commitment to data quality and compliance.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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