Clinical Sample Manager
Employment Type: Full-Time
Title: Clinical Sample Manager
Manager: Dan Johnson
Department: Clinical Operations
Partnering closely with internal and external cross-functional teams, the Clinical Sample Manager will provide the detailed oversight and support necessary to manage the lifecycle of biosamples (laboratory selection and oversight, sample collection, processing, analysis, data receipt and final sample repository/disposition) for all RAPT clinical trials. The Clinical Sample Manager possesses the technical and operational expertise needed to ensure effective delivery of laboratory data and completion of other lab-related activities to meet project milestones in support of RAPT's Clinical Development goals.
* Point of contact and functional lead for all operational activities relating to the central lab and specialty lab vendors and sample management
* Partners with RAPT Biology and Biomarker Team staff, as well as external personnel (Central Labs, specialty labs, trial site labs, etc.), on clinical laboratory activities including sample management, inventory tracking, sample logistics, data management, issue resolution, and risk identification
* Develops/Implements clinical sample collection/biomarker strategy across multiple clinical trials/programs and ensure its execution in accordance with the requirements of quality, ethical and regulatory guidelines, including ICH/GCP/GLP, and RAPT SOPs
* Ensures collection, processing, storage, delivery, and analysis of clinical samples under the highest standards of quality, ethics, and informed consent across all RAPT clinical trials.
* Establishes, implements, and maintains processes for sample management throughout the lifecycle of each sample, including development of SOPs, for consistent practices across RAPT clinical trials.
* Oversees set-up, implementation, and maintenance of a clinical sample management system for global clinical trials
* Assists in the development of study-specific sample management plans and documentation, including vendor agreements, laboratory specification documents, relevant sections of Informed Consent Forms and Clinical Study Protocols, and training materials for site personnel performing sample collection, processing, and shipping.
* Contributes to identification, selection and contracting of central and specialty laboratories and other sample-related vendors, including the development of vendor scopes of work (SOWs). Oversees the RAPT internal contract review and approval process.
* Manages interactions with contract analytical labs including technology transfers, budgets, contract management, and data transfer agreements
* Develops and maintains internal trackers/dashboards representing metrics and trends related to clinical trial samples, analyses, and results. Presents on processes, sample analysis stats, and results to study teams and management teams, as needed.
* Contributes to the CRF development process to ensure biomarker sampling information is appropriately collected for sample tracking and reconciliation purposes
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
* BA/BS or equivalent degree (in a scientific discipline or related healthcare field is preferred but is not required). Further qualification, e.g. PhD and/or project management certification is desirable.
* Approximately 2-4 years of biosample coordination/management and/or clinical research experience in a pharmaceutical / biotechnology company and/or CRO, or equivalent experience in a clinical/diagnostic laboratory
* Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials (experience in global trials preferred)
* Strong understanding of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, and particularly international regulations related to sample collection and logistics in clinical trials
* Well-developed project management, project execution, communication, and presentation skills.
* In-depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook
* Strong interpersonal and communication skills (verbal and written); effective in interaction and collaboration with senior and junior colleagues, both internal and external
* Ability to work on complex projects and perform multiple tasks, often with tight timelines and with minimal supervision
* Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials