[Innovative Medicine]Lead Clinical Science Oncology Biomarker Operations(Contractor)

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Job Function:
Non-Standard

Job Sub Function:
Non-Employee

Job Category:
Non-Standard

All Job Posting Locations:
Shanghai, China

Job Description:


* Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology, align with the Global team to enable seamless operations of Chinese studies.

Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and 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


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