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Biomarker Program Manager II

2 months ago

North Chicago Illinois, United States AbbVie Full time
About the Role

We are seeking a highly skilled Biomarker Program Manager II to join our team at AbbVie. As a key member of our Precision Medicine Biomarker Program Management group, you will play a critical role in implementing and managing biomarker research in multiple Phase 1-3 clinical trials.

Key Responsibilities
  • Manage biomarker operations and logistics to align with clinical trial schedules.
  • Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial.
  • Contribute to the development of relevant clinical study documents and associated systems.
  • Respond to EC/IRB biomarker-related inquiries and ensure consistent responses across studies.
  • Manage biomarker vendor selection and research scope, as well as contract execution and vendor oversight.
  • Responsible for accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics, and shipping.
  • Generate study-related training for the study team, study sites, and vendors for each trial.
  • Coordinate sample analysis and data transfer, ensuring timely shipments to vendors and/or storage sites.
  • Oversee sample analysis and data transfer, ensuring timely shipments to vendors and/or storage sites.
  • Responsible for sample management, storage, and/or destruction per requirements.
  • Deposit biomarker-related documents to the Trial Master File, ensuring that documentation standards are followed and are 'inspection-ready'.
  • Proactively identify and resolve or escalate study-related issues.
  • Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices, and ethical guidelines.
  • Serve as a subject matter expert (SME) and resource for one or more processes in BPM.
  • Participate in process improvement initiatives and contribute to a positive and motivating work environment.
About AbbVie

AbbVie is a global biopharmaceutical company that uses advanced methods to discover biomarkers for use in clinical trials. Our Precision Medicine group is dedicated to helping serve patient needs and furthering our innovative biopharmaceutical pipeline.