Senior Sample Management Specialist at Precision Medicine Group

Pune, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sample Management, Data Quality, Clinical Studies, Logistics, Database Management, Quality Control, Communication, Training, Root Cause Analysis, SOP Development, Process Optimization, Inventory Management, KPI Monitoring, LIMS, Microsoft Office, Trend Analysis

Industry

Pharmaceutical Manufacturing

Description

Position Summary The Senior Specialist, Sample Management is responsible for the support, coordination, and training of Sample Management activities and initiatives focused on discrepancy tracking and resolution (including customer/site outreach), database troubleshooting and modifications stemming from internal requests and external data reconciliations, and quality control review of data entered to ensure compliance with operating procedures and study-specific data entry requirements. Additionally, the Senior Specialist is expected to work with internal leadership on alignment of resources, initiatives, KPIs and performance trends, and tasks to ensure overall execution of company vision and directives. Key Responsibilities Lead global sample tracking, kit logistics, and discrepancy resolution across multiple clinical studies by collaborating with cross-functional teams to ensure seamless sample lifecycle execution. Oversee kit preparation, distribution, and site coordination to ensure timely and compliant sample collection. Interpret study protocols and lab manuals to apply sample workflows. Serve as primary point of contact for clinical sites, CROs, and clients regarding sample documentation, training, and compliance. Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems. Lead study setup in LIMS, including protocol configuration and sample workflow parameters. Support study monitoring and close-out activities, including reconciliation and final disposition of samples. Manage sample inventory requests and coordinate data transfers to clinical repositories per study timelines. Monitor patient sample collection schedules and protocol-defined assessment windows to ensure timely and compliant sample receipt. Monitor and report KPIs related to sample quality, turnaround times (TATs), and operational performance. Prepare and maintain operational reports including sample inventory, kit tracking, and site performance metrics. Participate in root cause analysis and corrective actions for sample-related quality events. Contribute to SOP development, process optimization, and training of junior staff. Assist with setting up new studies by thoroughly understanding study design and sample management requirements from the protocol, PSD and lab manual. Assist with documentation of sample related issues, corrections and compliance with QMS standards. Support ad hoc requests for analysis and other duties as assigned. Department: Data Operations / Biorepository Support Qualifications Minimum Requirements Minimum of 5-6 years of relevant experience. Comprehensive understanding of drug, device, and/or biologic development processes. Experience with clinical database management systems. Strong expertise in data quality standards and practices. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Excellent organizational, written, and verbal communication skills in English. Preferred Qualifications Bachelor’s / master’s degree in a life science related field Background in clinical, scientific, or healthcare disciplines. Familiarity with data privacy regulations (e.g., GDPR, HIPAA). Experience with Power BI, Power Query, and/or Power Automate. Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems. Experience using Smartsheet for project tracking and collaboration. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Responsibilities

The Senior Specialist will lead global sample tracking and discrepancy resolution across clinical studies while collaborating with cross-functional teams. They will also oversee kit logistics and ensure compliance with sample collection protocols.