Biomarker Operations Manager

About Abb Vie

Abb Vie'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, as well as the products and services in our Allergan Aesthetics portfolio.

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.

The role will drive innovation and continuous improvement activities in bio‑sample collection, processing and transfers, and demonstrate the ability to carry out all bio‑sample operations with minimal supervision.

• Plan, organize, and oversee the collection and shipping of bio‑samples from investigator sites or centralized locations and subsequent delivery to assay laboratories or Abb Vie.
• Partner with the 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 the correct databases for each assigned study, reconciling 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, and create edit checks for each sample type within assigned trials.
• Manage relationships with laboratory vendors, provide input into trial‑specific documents, 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 confirm completion, and help project managers with contract execution and vendor oversight in compliance with Abb Vie procedures and applicable regulations.
• 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 improve efficiency as needed, and contribute to 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 required.

• Master’s degree with 0+ years of project management, oncology, and/or clinical‑trial experience or a 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 detail, 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.

• 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…