Senior Project Specialist, Sample Operations
AbbVie
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
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 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.
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.
Qualifications
- 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits thatare allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole andabsolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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