Senior Project Specialist, Sample Operations
AbbVie•North Chicago, IL
•$96,500 - $183,500
About The Position
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 needed for complex issues that arise with the sample receiving team. Represent LSO team in vendor meetings to ensure timely response to projects and/or identified issues. Act as primary liaison with Bioanalysis (and other partnered departments) to ensure that priority project deliverables are met.
Requirements
- Bachelor’s degree in life sciences or equivalent field of study is required.
- Must have 6+ years of sample processing experience in a GLP regulated environment.
- Must have demonstrated skills in a regulated environment.
- Must have demonstrated strong leadership competencies with broad business orientation.
- Must have demonstrated experience in cross-functional team environment (specifically IT, Bioanalysis, Clinical Systems).
- Knowledgeable in the end-to-end sample lifecycle.
- Proficient with applicable LIMS software.
- Leader and key contributor to initiatives and advancement of LSO as an organization.
Responsibilities
- Plans and manages LSO timelines for assigned clinical trials, specifically the completion of the Lab Specifications and Kit Delivery.
- Participates in vendor meetings to ensure proper representation for LSO and timely resolution of outstanding issues.
- Manages all process flows and data exchanges with any vendors or internal data providers/consumers.
- Assists with the development of trial-specific SOW based on parameters supplied with MSA with applicable vendor and clinical protocol.
- Participates in cross-functional meetings where LSO tasks are discussed.
- Continually seeks to improve on existing processes.
- Manages and maintain vendor budgets for assigned clinical trials.
- Develops productive collaborations and communication with other cross functional groups.
- Functions as a team leader on projects, and effectively coordinates activities.
- Ensures compliance with current SOPs.
- Participates in any internal quality assurance audits.
- Manages sample storage volumes and the sample lifecycle management process.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
