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Biomarker Program Manager
2 months ago
We are seeking an experienced and highly motivated individual to join our Biomarker Program Management team as a Biomarker Program Manager - Clinical Trials. This role will be responsible for managing biomarker operations and logistics to support clinical trial schedules, ensuring data are ready for analysis per timeline.
Key Responsibilities- Manage biomarker operations and logistics to support clinical trial schedules, ensuring data are ready for analysis per timeline.
- Resolve or escalate biomarker study-related issues with PMed Lead or BPM Subject Matter Expert (SME).
- Contribute to the development of relevant biomarker content in clinical study documents and associated systems.
- Respond to queries from EC/IRB with guidance from PMed Lead or BPM SME, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines.
- Generate study-related training materials for the study team, study sites, and vendors for each trial.
- Support biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with AbbVie's procedures and applicable regulations.
- Contribute to the accurate forecasting and tracking of study costs associated with sample and results management, bioanalytical assays, logistics, and shipping, as needed.
- Identify process or training gaps and suggest improvements.
- Work with PMed Lead(s) to articulate biomarker strategy in appropriate internal documents.
- Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.
- Proven track record of clinical trial experience and decision-making to achieve objectives.
- Scientific expertise, strategic thinking, a patient-oriented mindset, team building, and cross-functional collaboration.
- Ability to work independently and balance multiple priorities in a fast-paced, team-based environment.
- Application and adherence to ICH/GCP, biorepository procedures, biosample management best practices, and ethical guidelines.
