Senior Sample Management Specialist
Location: Pune, Maharashtra, India
Department: Data Operations / Biorepository Support
Employment Type: Full-time
About the Role
We are seeking an experienced Senior Sample Management Specialist to lead and support end-to-end sample management operations across global clinical studies. This role plays a critical part in ensuring compliant, accurate, and timely handling of clinical samples by overseeing discrepancy management, database integrity, quality control, and cross-functional coordination.
The position requires strong expertise in clinical sample lifecycle management, laboratory data systems, and quality-driven processes, along with the ability to collaborate with internal leadership, clinical sites, CROs, and external stakeholders to drive operational excellence.
Key Responsibilities
Lead global sample tracking, kit logistics, and discrepancy resolution across multiple clinical trials
Coordinate kit preparation, distribution, and site engagement to ensure compliant and timely sample collection
Interpret study protocols, lab manuals, and project specifications to implement accurate sample workflows
Serve as the primary contact for clinical sites, CROs, and sponsors regarding sample documentation, training, and compliance
Perform advanced quality control reviews, trend analysis, and data reconciliation within LIMS and sample inventory systems
Lead study setup and configuration in Laboratory Information Management Systems (LIMS), including workflow parameters
Support study monitoring, reconciliation, close-out activities, and final disposition of samples
Manage sample inventory requests and coordinate data transfers to clinical repositories within defined timelines
Monitor patient sample collection schedules and protocol-defined assessment windows
Track, analyze, and report key performance indicators (KPIs) related to sample quality, turnaround time (TAT), and operational performance
Prepare and maintain operational reports covering inventory status, kit tracking, and site performance
Participate in root cause analysis, CAPA activities, and resolution of sample-related quality events
Contribute to SOP development, process optimization, and training of junior team members
Support new study setup by reviewing protocols, lab manuals, and project-specific documentation
Ensure documentation and issue resolution in compliance with Quality Management System (QMS) standards
Support ad hoc operational analyses and additional responsibilities as assigned
Experience Required
Minimum 5–6 years of relevant experience in clinical sample management, biorepository operations, or data operations
Proven experience supporting drug, device, and/or biologic development programs
Hands-on experience with clinical database management systems and laboratory data workflows
Strong background in data quality standards, discrepancy management, and compliance-driven operations
Educational Qualifications
Bachelor’s or Master’s degree in a Life Sciences discipline (preferred)
Background in clinical research, scientific, laboratory, or healthcare environments is advantageous
Required Skills & Competencies
Strong working knowledge of LIMS and biospecimen inventory systems
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
Excellent organizational, analytical, and problem-solving skills
Strong written and verbal communication skills in English
Ability to manage multiple studies and priorities in a fast-paced global environment
Preferred Skills
Familiarity with data privacy regulations such as GDPR and HIPAA
Experience with Power BI, Power Query, Power Automate for reporting and analytics
Hands-on experience with Smartsheet for project tracking and collaboration
Why Join
This role offers the opportunity to work at the intersection of clinical operations, laboratory science, and data governance. You will contribute directly to the integrity of clinical trial data, collaborate with global teams, and play a key role in advancing precision medicine and patient-focused research.
Equal Opportunity Statement
The organization is an Equal Opportunity Employer and is committed to building a diverse and inclusive workplace. Employment decisions are made without regard to race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status. Reasonable accommodations are available throughout the recruitment process.
Gujarat :
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