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Role at a glance
You will
Review protocol and lab CRFs during study set up phase to ensure Lab Normal Management Tool is configured accurately
Review lab slips and documents for Normal Reference Ranges for all protocol-required lab tests
Maintain Lab IDs and update normal reference ranges in the database
Experience
3–5 years
Must-have skills
MS OfficeProject Management
Work mode
On-site
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Job description
Location: Chennai, India Department: Healthcare
We are seeking a Lab Data Specialist to join our team in Chennai, India. The successful candidate will be responsible for ensuring the accuracy and integrity of laboratory data in clinical trials.
Role Responsibilities
Review protocol and lab CRFs during study set up phase to ensure Lab Normal Management Tool is configured accurately
Create protocol-specific templates for capturing missing lab parameters
Review lab slips and documents for Normal Reference Ranges for all protocol-required lab tests
Maintain Lab IDs and update normal reference ranges in the database
Support both Local and Central lab IDs for all Pfizer studies
Create and maintain Lab Test Questions Library, Lab test units, and conversions into SI units
Develop, maintain, and update all Lab-related SOP documents and guidelines
Support implementation of Clinical Data Interchange Standards Consortium (CDISC) Lab data standards and LOINC code
Serve as a technical Subject Matter Expert (SME) to study teams and data managers for analysis and remediation of lab data discrepancies
Provide guidance to study management for collection of complete and accurate Reference range documents from Investigator sites
Analyze and resolve lab data issues
Basic Qualifications
BS degree in a life science discipline with 3-5 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency
Understanding of drug development process and data operations required for reporting clinical trial data
Experience in clinical data management and EDC systems
Strong communication, decision-making, influencing, negotiation, and project management skills
Proficiency in Microsoft Office Suite of tools
Physical/Mental Requirements
Primarily an office-based position involving sitting in front of a computer for large periods of work time
Non-Standard Work Schedule, Travel or Environment Requirements
