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
Submit Resume
To apply for this job email your details to info@clinlabstaffing.com