Overview In this role you support clinical trial design and execution within the hematology and coagulation space. You collaborate with the service operations team to ensure study readiness and logistics, verify technical conditions, and assist with R&D activities and product launches. You will maintain QA/QC, manage documentation, and help train staff on instrumentation, contributing to compliant, scalable trial operations.
Responsibilities- Support clinical trial designs and execution with regulatory input
- Assist in R&D activities and development of hematology/hemostasis products
- Verify technical conditions before study start and manage study logistics with the service operations team
- Ensure protocol understanding and on-time study progress; coordinate site initiation and monitoring activities
- Maintain data traceability, database freezes, and proper completion of records (paper/electronic)
- Perform instrument validation tasks including Linearity, Method Comparison, LOD, LOQ, and interference checks
- Maintain and QC laboratory equipment; participate in validation of new equipment
- Assist in development and maintenance of clinical study binders and use of eCRF
- Manage laboratory equipment service contracts and clinical trial documentation from the site's perspective
- Prepare and deliver scientific presentations and support new product launches
Key requirements- Bachelor in Medical Technology/Clinical Laboratory Science or equivalent
- MT(ASCP) Certification or equivalent preferred
- Minimum five years experience in Hematology and Coagulation
- Experience with instrument validations, correlations, and training lab staff on new instrumentation
- Experience with clinical trial regulations and execution in laboratory settings
- attention to detail
- strong organizational and documentation skills
- ability to work with cross-functional teams
- instrument validation (Linearity, Method Comparison, LOD, LOQ)
- interference testing and stability assessments
- quality control and preventive maintenance of analyzers
