Associate Data Manager, Clinical Data Sciences
Company: Pfizer
Location: Chennai, India (Hybrid)
Department: Clinical Data Sciences / Worldwide Medical & Safety
Job Type: Full-Time
JOB OVERVIEW
The Associate Data Manager, Clinical Data Sciences is responsible for supporting clinical data management activities throughout the clinical trial lifecycle. The role involves data monitoring, query management, database validation, quality control, clinical data review, CTMS support, and ensuring compliance with ICH-GCP guidelines and regulatory standards. The Associate Data Manager collaborates with cross-functional study teams to maintain accurate, high-quality clinical trial data that supports regulatory submissions and drug development.
KEY RESPONSIBILITIES
Clinical Data Management
Perform clinical data review and validation.
Monitor clinical trial data for quality and completeness.
Manage clinical databases throughout the study lifecycle.
Support clinical data collection activities.
Ensure data integrity and consistency.
Data Monitoring & Query Management
Perform Data Monitoring and Management (DMM) activities.
Review clinical data for discrepancies.
Generate, manage, and resolve data queries.
Investigate logic check flags.
Follow up on outstanding data issues.
Database Design & Validation
Support database design activities.
Perform User Acceptance Testing (UAT).
Validate clinical databases.
Test electronic data capture systems.
Implement clinical data collection tools.
Clinical Trial Management System (CTMS) Support
Serve as the first point of contact for CTMS users.
Resolve CTMS-related issues.
Provide system support to study teams.
Assist users with clinical data management systems.
Documentation & Trial Master File (TMF)
Review study documentation.
Resolve document discrepancies.
Support Trial Master File (TMF) management.
Coordinate with document owners.
Maintain inspection-ready documentation.
Quality Assurance & Compliance
Ensure compliance with ICH-GCP guidelines.
Follow Standard Operating Procedures (SOPs).
Maintain regulatory compliance.
Support quality control activities.
Ensure adherence to data standards.
Cross-Functional Collaboration
Work closely with Study Teams.
Coordinate with TMF Study Owners.
Collaborate with Clinical Operations.
Communicate with internal stakeholders.
Support project-related activities.
Process Improvement
Participate in continuous improvement initiatives.
Identify workflow enhancements.
Support implementation of best practices.
Contribute to operational excellence projects.
Technology & AI
Utilize electronic documentation management systems.
Work with web-based clinical data management systems.
Use AI tools (e.g., ChatGPT, Microsoft Copilot) responsibly to improve productivity.
Follow ethical AI and data governance practices.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree (BA/BS) in:
Life Sciences
Pharmacy
Biotechnology
Biological Sciences
Health Sciences
Related Discipline
EXPERIENCE REQUIREMENTS
Required
Experience in Clinical Data Management or Clinical Research is preferred.
Knowledge of ICH-GCP documentation requirements.
Experience with electronic documentation management systems or web-based data management systems.
Preferred
Experience with Clinical Trial Management Systems (CTMS).
Experience in data validation and quality control.
Familiarity with AI productivity tools such as ChatGPT or Microsoft Copilot.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
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