Senior Project Specialist, Sample Operations

Job Title

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.

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.

• 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.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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.

Abb Vie 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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Pay Range: $96500 - 183500 USD

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays.

Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.