About the job
- The Senior Sample Management Specialist plays a pivotal role in overseeing, coordinating, and training on Sample Management initiatives. This includes tracking and resolving discrepancies, facilitating customer or site communication, troubleshooting database issues resulting from internal requests, and conducting quality control reviews to ensure compliance with operational procedures and study-specific data entry needs.
- This position requires collaboration with internal leadership to align resources, initiatives, key performance indicators (KPIs), and performance trends to ensure the successful execution of the company’s vision and goals.
Key Responsibilities
- Lead global sample tracking, kit logistics, and discrepancy resolution for various clinical studies by working closely with cross-functional teams to ensure efficient sample lifecycle management.
- Manage the preparation and distribution of kits, as well as site coordination to ensure timely and compliant sample collection.
- Interpret study protocols and lab manuals to effectively implement sample workflows.
- Act as the primary contact for clinical sites, Contract Research Organizations (CROs), and clients regarding sample documentation, training, and compliance matters.
- Conduct advanced quality control checks and trend analysis on sample data within Laboratory Information Management Systems (LIMS) and inventory systems.
- Oversee study setup in LIMS, including configuring protocols and establishing sample workflow parameters.
- Assist with study monitoring and close-out activities, including sample reconciliation and final disposition. Manage sample inventory requests and coordinate data transfers to clinical repositories according to study timelines.
- Track patient sample collection schedules and ensure compliance with protocol-defined assessment windows for timely sample receipt.
- Monitor and report on KPIs related to sample quality, turnaround times (TATs), and operational performance.
- Prepare and maintain operational reports detailing sample inventory, kit tracking, and site performance metrics.
- Participate in root cause analysis and corrective actions for any sample-related quality events.
- Contribute to the development of Standard Operating Procedures (SOPs), process optimization, and training for junior staff members.
- Support the setup of new studies by thoroughly understanding study design and sample management requirements as outlined in the protocol, Product Specification Document (PSD), and lab manuals.
- Assist in documenting sample-related issues and ensuring compliance with Quality Management System (QMS) standards.
- Provide support for ad hoc requests for analysis and perform other duties as assigned.

