Clinical Sample Manager

Direct Hire/Full Time

We are seeking a  Clinical Sample Operations Manager to plan and coordinate all operational activities required for the collection, delivery and testing of clinical biomarker or diagnostic samples within a clinical study.

Primary Responsibilities and Accountabilities:

• Responsible for the development and implementation of the clinical biomarker operations strategy, including CRO management, lab manual generation, sample collection and shipping logistics, and budget, etc.
• Aligns processes surrounding vendor selection and management

• Acts as the primary point of escalation for issue resolution

• Provides input on Protocol and ICF development
• Identifies novel and innovative clinical sample collection and processing techniques and ensures logistical feasibility
• Manage timelines for sample testing and data transfer with both internal teams and external vendors
• Single point of contact for status of clinical trial samples and biomarker data, provide sample and assay status updates
• Manage sample transfer/discrepancy resolution with Central Lab and other sample analysis/storage CROs
• Support/participate in preclinical biomarker identification effort as needed

Requirements:

• Bachelor’s Degree in scientific or related field and a minimum of 3-5 years’ related experience;
• Experience with NGS preferred;
• CRO/vendor selection and management experience preferred
• Clinical sample handling and management;
• Drafting and reviewing of lab related clinical trial documents (protocol, ICF, lab manual, etc.), preferred