Sample Management Specialist at Precision for Medicine

Pune, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sample Management, Discrepancy Tracking, Database Troubleshooting, Quality Control, Data Entry, Clinical Database Management, Data Quality Standards, Microsoft Office Suite, Organizational Skills, Communication Skills, Trend Analysis, LIMS, Biospecimen Inventory Systems, Root Cause Analysis, Compliance, Data Privacy Regulations

Industry

Pharmaceutical Manufacturing

Description

Position Summary The 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. Key Responsibilities Maintain global oversight of unresolved discrepancies identified by internal sample management teams for both incoming and outgoing shipments. Work directly with sample management teams to receive any additional clarification or justification as needed. Communicate and/or execute appropriate resolution actions to close discrepancies in a timely manner to meet customer and business deliverables on TAT and OTIF. Identify and consult on trends related to sample discrepancies observed with internal teams, collection sites, and/or established data entry/study requirements Provide necessary study close-out support for sample management including internal assessment of data, sample dispositions and resolve any reconciliation queries and actions. Perform quality control (QC) verification of data entry performed by global sample management teams to ensure compliance/alignment to data entry requirements in accordance with project-specific operating procedures and incoming source documents Identify, and clarify as needed, data corrections stemming from misalignments observed from prescribed data entry requirements Perform advanced QC checks and trend analysis on sample data in LIMS and inventory systems. Study setup in LIMS, including protocol configuration and sample workflow parameters. Monitor patient sample collection schedules and protocol-defined assessment windows to ensure timely and compliant sample receipt. 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. 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 2-3 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). Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems. 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 Sample Management Specialist is responsible for overseeing discrepancy tracking and resolution, database modifications, and quality control of data entry. They will also provide support for study close-outs and perform advanced quality checks on sample data.