#2406227216W
quality metrics during study startup, conduct and closeout
Works effectively with scientific leads, procurement, contracting team and compliance team to evaluate vendor capability and certificate, and prepare contracts and statement of work; oversee the contract execute status and ensure the delivery meet program requirements.
Makes joint effort with Clinical Operation for HGR application for both molecular eligibility screening and exploratory biomarker.
Timely monitors sample/data collection being under HGR approval throughout the study. Coordinates internal and external parties for regular or unscheduled HGR audits.
Supports Clinical operation and biomarker central lab for site staff training and refreshes sample requirement from central lab.
Leads central lab setup and management throughout the course of a study, works as a bridge between central lab and internal stakeholders and maintains good relationships with internal and external partners.
Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications
Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs
Contributes to the preparation of clinical documents such as lab report template, lab manuals, informed consent forms, eCRF, sample/data management plan, early development plans and site training materials
Works with scientific stakeholders to identify innovative bio-sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards
Develops presentations and presents sample tracking/testing metrics at regular team meetings
Supports scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program
Participates and make TR/CDx operation update in cross-functions study team meetings across clinical, translational research and diagnostics.
Supports scientific leads to find central testing issues, provide efficient solutions from operation perspective.
Qualifications