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Specialist, Biomarker Operations

4 months ago

North Chicago, IL, United States Abbvie Full time

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Translational Oncology group at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to further AbbVie’s innovative Oncology pipeline. The Biomarker Operations Specialist works closely with clinical operations, project managers and laboratory managers to ensure timely and smooth collection, transfer and testing of clinical trial biospecimens in compliance with protocols, regulatory requirements and project timelines. This role is responsible for identifying projects/tasks together with laboratory managers and works with Clinical Operation 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 Clinical Biomarker 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 data and samples 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's procedures and applicable regulations. May oversee laboratory vendor deliverables against the scope of work
  • In partnership with Clinical Operations, Clinical Biomarker 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

  • Master’s Degree with 0+ years project management, oncology and/or clinical trial experience
  • Bachelor’s 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 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. ​

Note: No amount of pay is a 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.