Description
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
- Ability to travel ~5%