Biomarker Program Manager II
4 days ago
AbbVie is seeking a highly skilled Biomarker Program Manager II to join our Precision Medicine Biomarker Program Management (BPM) group. As a key member of our team, 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
- Collaborate with lead biomarker scientists to provide regular updates to cross-functional stakeholders
- Contribute to the development of 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
- Forecast and track study costs associated with sample and result management, bioanalytical assays, logistics, and shipping
- Develop and deliver study-related training for the study team, study sites, and vendors
- Coordinate sample analysis and data transfer, ensuring timely shipments to vendors and/or storage sites
- Oversee sample management, storage, and/or destruction per requirements
- Deposit biomarker-related documents to the Trial Master File, ensuring documentation standards are followed
- Proactively identify and resolve study-related issues and escalate as needed
Requirements:
- Strong scientific expertise and strategic thinking
- Excellent communication and collaboration skills
- Ability to work independently and balance multiple priorities in a fast-paced environment
- Experience with ICH/GCP, bio-storage procedures, bio-sample management best practices, and ethical guidelines
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.
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