
Posted 12 hours ago
Sample Management Specialist
Precision Medicine GroupSample Management Specialist
Requirements
2-3 years relevant experience, Understanding of drug/biologic development, Clinical database management experience, Data quality expertise, Microsoft Office proficiency, English fluency
Skills
LIMSData QualityClinical Data Management
About the role
Responsibilities
- Maintain global oversight of unresolved discrepancies for incoming and outgoing sample shipments
- Execute resolution actions to meet customer and business deliverables
- Identify and consult on trends related to sample discrepancies
- Provide study close-out support including data assessment and sample dispositions
- Perform quality control (QC) verification of data entry for compliance with operating procedures
- Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems
- Manage study setup in LIMS including protocol configuration and workflow parameters
- Monitor patient sample collection schedules and protocol-defined assessment windows
- Prepare operational reports including sample inventory and site performance metrics
- Participate in root cause analysis and corrective actions for quality events
- Assist with documentation of sample issues and compliance with QMS standards
Requirements
- 2-3 years of relevant experience
- Comprehensive understanding of drug, device, or biologic development processes
- Experience with clinical database management systems
- Expertise in data quality standards and practices
- Proficiency in Microsoft Office Suite
- Excellent English communication skills
Preferred Qualifications
- Bachelor's or Master's degree in a life science related field
- Background in clinical, scientific, or healthcare disciplines
- Familiarity with data privacy regulations such as GDPR or HIPAA
- Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems
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Precision Medicine Group · Pune
