Clinical Biosample Manager/Sr. Manager

Position Summary

Essential Responsibilities

• Work with functional groups to understand protocol sample requirements and identify vendors and providers capable of performing such activities. Manage the vendor selection process from identification through selection and study set-up.
• Be the point of contact for sample management for bioanalytical labs including PK, ADA, Dx, and PD.
• Work with the functional groups that is responsible for planning, organization, and oversight of the entire lifecycle of clinical samples. Closely collaborate with translational, clinical sciences, clinical operations, and other involved clinical developmental groups.
• Maintain oversight of all study biosample operational activities, including sample reconciliation, sample metrics, and reporting, data delivery and cleaning process, and final sample disposition.
• Evaluate the cross-programs performance of lab vendors and be responsible for cross-portfolio alignment.
• Provide high-level forecasting of sample size, timelines, scenario planning, and feasibilities and any estimation of budget, turn-around time or additional resources required.
• Provide regular portfolio level updates on timelines, risks, and logistics with the study, biomarker, and clinical teams across programs.
• Establish, implement, and maintain processes for sample management.
• Participate in the identification, selection, and oversight of laboratory vendors.
• Participate in protocol and IB reviewing and clinical trial start-up activities, provide inputs on data management plans, iDMB, UAT and ICF reviews as it relates to clinical sample collections and management.
• Develop the strategy for a scalable sample storage, tracking, and access.
• Ensures study adherence to ICH/GCP/GLP, data management, regulatory, legal, and quality assurance issues/processes, and SOPs.
• Represent Translational Medicine and Clinical Science on clinical study management teams and serve as subject matter expert for sample operations and technical aspects of sample collection, storage and shipping.
• Manage kit building and central laboratory CROs to develop work orders, kit specifications and Lab Manuals as necessary to enable sample collection.
• Proactively identify and resolve and/or escalate study-related issues.
• Responsible for sample management, storage, and/or destruction per requirements.
• Analyze clinical sample inventories to identify missing samples.
• Publish updates to communicate sample collection performance metrics to team. Open and track queries to resolve issues with samples.
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed.

Education and Experience Requirements

• Master’s degree or bachelor’s degree with 4+ years project management, sample management, or clinical operations experience, clinical lab experience.
• Expertise in MS Office applications, especially in using Excel to analyze and visualize data. 
• Experience managing laboratory CRO vendors or working with pharma sponsors as a CRO project manager.
• Excellent oral and written communication skills in English.
• Organizational skills, attention to detail, and effective time management with ability to adapt to changing priorities, excellent analytical and interpersonal skills.
• 2+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred.
• Scientific background or proven enthusiasm working on scientific initiatives, especially in oncology or translational science preferred.
• Ability to work with minimal supervision.
• Experience extracting and analyzing data from clinical databases, vendor data portals, LIMS, or in-house databases preferred.
• Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus. 
• Collaborative, team-oriented mindset with strong verbal and written communication skills. 
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills. 

Industry

• Biotechnology

Employment Type

• Full-time

Equal Employment Opportunity