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Clinical Biomarker Sample Operations Senior Manager
2 months ago
Takeda is a global biopharmaceutical company committed to delivering innovative therapies to patients worldwide. We are seeking a highly skilled Clinical Biomarker Sample Operations Senior Manager to join our team in Cambridge, MA.
Key Responsibilities- Develop and implement strategies for the lifecycle management of clinical bioanalytical and biomarker samples, data, and specialty lab vendors to maintain chain-of-custody in a GxP-compliant setting.
- Collaborate with cross-functional teams to standardize and harmonize end-to-end biospecimen activities across clinical trials, maximizing biomarker specimen accrual and quality.
- Design and operationalize processes for sample and data management, including vendor onboarding, sample tracking, analysis, data delivery, and management.
- Work with the Biomarker Science & Technologies (BST) group to advance the mission of BST and its contributions to the clinical program lifecycle.
- Develop and maintain metrics for specialty lab vendor management and oversee escalations, governance, and contract management.
- Support audit and inspection preparation for Takeda QA specialty lab audits and Agency inspections.
- PhD degree in a scientific discipline with 3+ years of experience, or MS with 9+ years of experience, or BS with 11+ years of experience.
- Knowledge of drug development, clinical trial principles, and understanding of the role of bioanalysis and biomarkers in clinical studies.
- Experience in sample management activities across multiple projects.
- Excellent written, organizational, and interpersonal communications skills.
- Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
