Manager Biospecimen

Role Overview: You will be responsible for managing biospecimens collected for clinical studies, working closely with Clinical Teams to develop and implement biospecimen management plans for Phase 1-4 clinical trials. Your role will involve overseeing the complete lifecycle of biospecimens, ensuring timely delivery of specimen data, and facilitating quick decision-making processes to maintain a competitive advantage. Key Responsibilities: - Oversee and manage biospecimens collected for clinical studies with minimal supervision. - Provide shipping/sample movement and management support to Clinical Team members, including handling requests, queries, and inventory reports. - Follow up on active issues with vendors, prepare sample management related reports, review/prepare tracking activities, and ensure proper documentation. - Independently review clinical study protocols, provide comparison of vendor statements of work, and offer feedback as needed. - Perform routine vendor management responsibilities, including accessing necessary vendor/system inventory files for specimen tracking. - Create biospecimen trackers using various tracking tools like MS Excel, Spotfire, Tableau, or internal systems under direction. - Exercise judgment within policy and procedure boundaries, troubleshoot routine problems, and seek guidance when necessary. Qualifications Required: - Minimum of 3-4 years of experience in academic, biotech, healthcare, or pharmaceutical industry. - Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues. - Demonstrated experience in clinical trials, healthcare/medical/laboratory settings, or equivalent. - Vendor experience preferred, such as with Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. - Biospecimen management experience is a plus but not mandatory. - Strong communication skills with the ability to create and deliver presentations to knowledgeable audiences. - Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, act with a sense of urgency and integrity, and have fun along the way. - Minimal travel requirement of 0%-5% of time when organization requests.,