Biomarker Operations Manager

The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. The Biomarker Operations Manager works closely with clinical operations project managers and laboratory managers to ensure timely and smooth collection transfer and testing of clinical trial biomarker specimens in compliance with protocols regulatory requirements and project timelines. This role is responsible for identifying projects/tasks together with laboratory managers and works with biomarker study management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection processing and transfers and demonstrate ability to carry out all bio-sample operations with minimal supervision.

Responsibilities:

• Plan organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to assay laboratories or AbbVie. Partner with Biomarker Program Manager and Biomarker Lead Scientist to ensure the delivery of bio-sample data in accordance with study timelines. Ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases for each assigned study reconcile sample information stored in databases
• Responsible for functional process and system improvements to ensure samples are collected processed analyzed transported stored and destroyed appropriately
• Review study-specific documents related to sample collection handling analysis transport and storage as assigned. Create edit checks for each sample type within assigned trials
• Manage relationships with laboratory vendors provide input into trial-specific docs and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner. Review lab vendor invoices to ensure work has been completed. Help project managers with contract execution and vendor oversight in compliance with AbbVie procedures and applicable regulations. May oversee laboratory vendor deliverables against the scope of work
• In partnership with Biomarker Program Managers Biomarker Lead Scientists and IT contribute to the development and implementation of a sample tracking system for assigned studies
• Apply and adhere to ICH/GCP bio-storage procedures bio-sample management best practices and ethical guidelines
• Develop into a subject matter expert (SME) and resource for one or more processes in BPM
• Participate in process improvement initiatives or improving efficiency as needed as well as instructions and manuals for internal training purposes
• Contribute to a positive and motivating work environment that encourages mutual respect innovation and accountability at all levels mentor and develop team members as needed
• Balance multiple priorities in a fast-paced team-based environment and work independently when needed

Qualifications :

• Masters Degree with 0 years project management oncology and/or clinical trial experience or a Bachelors Degree with 4 years of project management oncology and/or clinical trial experience
• Expertise in MS Office applications including Excel Word and PowerPoint
• Excellent oral and written communication skills in English
• Organization attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills
• PMP certification a plus
• Clinical trial experience
• Scientific background and knowledge of oncology
• Ability to work with minor supervision

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 is earned  vested  and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Companys sole and absolute discretion unless and until paid and may be  modified at the Companys sole and absolute 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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Work :

No

Employment Type :

Full-time