Senior Project Specialist, Sample Operations

Purpose:
- Oversee the production of Lab Samples Operations (LSO) deliverables and timelines for assigned clinical trials.
- Oversee LSO-related cross-functional meetings for assigned clinical trials.
- Coordinate discrepancy resolution efforts for complex issues with the sample receiving team.
- Represent the LSO team in vendor meetings to ensure timely responses to projects and/or identified issues.
- Act as primary liaison with Bioanalysis (and other partnered departments) to ensure priority deliverables are met.

Responsibilities:
- Plan and manage LSO timelines for assigned clinical trials, including completion of Lab Specifications and Kit Delivery.
- Participate in vendor meetings for proper LSO representation and timely issue resolution.
- Manage process flows and data exchanges with vendors and internal data providers/consumers.
- Assist with development of trial-specific SOW based on MSA parameters, vendor, and clinical protocol.
- Participate in cross-functional meetings where LSO tasks are discussed.
- Improve existing processes; manage and maintain vendor budgets.
- Develop collaborations and communication with cross-functional groups.
- Lead projects and coordinate activities.
- Ensure compliance with current SOPs; participate in internal quality assurance audits.
- Manage sample storage volumes and sample lifecycle management process.

Qualifications:
- Bachelor’s degree in life sciences or equivalent field (required).
- 6+ years of sample processing experience in a GLP-regulated environment (required).
- Demonstrated skills in a regulated environment.
- Strong leadership competencies with broad business orientation.
- Experience in cross-functional teams (IT, Bioanalysis, Clinical Systems).
- Knowledge of end-to-end sample lifecycle.
- Proficiency with applicable LIMS software.
- Leader and key contributor to LSO initiatives and advancement.